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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
Sen. Con. Res. 11: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 - Amendments related to the biopharmaceutical industry including compounding/right to try; patent litigation reform; and non-interference, among others H. Con. Res. 27: Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 - Issues related to the biopharmaceutical industry including Part D and National Institutes of Health (NIH) funding H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · third_quarter · Q3
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
Source: Senate LDA
Protecting the Integrity of Medicare Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration Senate and House Reconciliation bills
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
Sen. Con. Res. 11: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 - Amendments related to the biopharmaceutical industry including compounding/right to try; patent litigation reform; and non-interference, among others H. Con. Res. 27: Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 - Issues related to the biopharmaceutical industry including Part D and National Institutes of Health (NIH) funding H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration
Protecting Seniors' Access to Medicare Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Protecting Seniors' Access to Medicare Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Bipartisan Budget Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
Bipartisan Budget Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
PATIENT Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
PATIENT Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
PATIENT Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Speeding Access to Already Approved Pharmaceuticals Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Speeding Access to Already Approved Pharmaceuticals Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Advancing Hope Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Advancing Hope Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Advancing Hope Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
National Defense Authorization Act for Fiscal Year 2016
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration
National Defense Authorization Act for Fiscal Year 2016
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration Senate and House Reconciliation bills
Grace Period Restoration Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Innovation Protection Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Medicare Access and CHIP Reauthorization Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Medicare Drug Savings Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Targeting Rogue and Opaque Letters Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Targeting Rogue and Opaque Letters Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Defending Public Safety Employees' Retirement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
Defending Public Safety Employees' Retirement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
Medicare Patient Safety and Drug Abuse Prevention Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Preservation of Access for Seniors in Medicare Advantage Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Antibiotic Development to Advance Patient Treatment Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Antibiotic Development to Advance Patient Treatment Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
FAST Generics Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
FAST Generics Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Combination Drug Development Incentive Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Combination Drug Development Incentive Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Combination Drug Development Incentive Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
21st Century Cures Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
21st Century Cures Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Improving Regulatory Transparency for New Medical Therapies Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Vaccine Access, Certainty, and Innovation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
American Research and Competitiveness Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
American Research and Competitiveness Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Innovation Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Innovation Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Innovation Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Andrea Sloan CURE Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Andrea Sloan CURE Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Andrea Sloan CURE Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Medicare Drug Savings Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
PATENT Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
PATENT Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Safe and Affordable Drugs from Canada Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Safe and Affordable Drugs from Canada Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Safe and Affordable Drugs from Canada Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Patient Access to Disposable Medical Technology Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
FAIR Generics Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
FAIR Generics Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
FAIR Generics Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Value-Based Insurance Design Seniors Copayment Reduction Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Saving Access to Compounded Medications for Special Needs Patients Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Protecting Seniors' Access to Medicare Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Protecting Seniors' Access to Medicare Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Combination Product Regulatory Fairness Act of 2016
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Safe and Affordable Prescription Drugs Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
PATH Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Preserve Access to Affordable Generics Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Prescription Drug Affordability Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Prescription Drug Affordability Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Advancing Targeted Therapies for Rare Diseases Act of 2016
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Promoting Life-Saving New Therapies for Neonates Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
American Cures Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
American Cures Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
American Cures Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Medicare Prescription Drug Price Negotiation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
Medicare Prescription Drug Price Negotiation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
Medical Innovation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Medical Innovation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Medical Innovation Act of 2015
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
FOIA Improvement Act of 2016
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration Senate and House Reconciliation bills
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · second_quarter · Q2
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, intellectual property, and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
Filing targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · first_quarter · Q1
Biopharmaceutical innovation policy issues China intellectual property and market access issues India innovation, IP and market access issues International market access and intellectual property issues Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Trade Promotion Authority issues Turkey market access issues U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access Canada intellectual property and market access issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures 21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues
Sen. Con. Res. 11: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 - Amendments related to the biopharmaceutical industry including compounding/right to try; patent litigation reform; and non-interference, among others H. Con. Res. 27: Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 - Issues related to the biopharmaceutical industry including Part D and National Institutes of Health (NIH) funding H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2014 · fourth_quarter · Q4
H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to Risk Evaluation and Mitigation Strategies (REMS) H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233 Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014)) 21st Century Cures legislation and policy issues R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014 Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA expedited drug approval policy issues Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling Issues relating to communications about prescription drugs 340B program policy issues Importation policy issues Clinical trial policy issues
H.R. 83, Making consolidated appropriations for the fiscal year ending September 30, 2015, and for other purposes: Provisions related to Food and Drug Administration (FDA) funding and oversight, 340B Drug Pricing Program, and other issues H.R. 3230, Veterans Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care program H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United State Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to FDA funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security H.R. 5464, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015: Provisions related to 340B program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), and Agency for Healthcare Research & Quality (AHQR) Preparation for the FY 2016 budget
H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to Office of Inspector General (OIG) enforcement of fraud and abuse laws H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models H.R. 5780, Protecting Integrity in Medicare Act of 2014: Provisions related to addressing fraud and prescription drug abuse S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Hospital Improvements for Payment (HIP) Act of 2014: Provisions related to Medicare reform (no bill number) Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence
H.R. 3803, Bipartisan Congressional Trade Priorities Act of 2014: Provisions related to trade agreements S. 1900, Bipartisan Congressional Trade Priorities Act of 2014: Trade promotion authority issues Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues Turkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues China intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues Trade Promotion Authority policy issues Colombia biosimilars policy issues
H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2639, Patent Litigation and Innovation Act: Patent litigation provisions H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014: Provisions related to targeted IP incentives for new indications for rare diseases or conditions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act: Patent litigation provisions S. 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets S. 3004, Dormant Therapies Act of 2014: Provisions related to incentives to develop biopharmaceutical products Biopharmaceutical innovation and patent policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
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2014 · third_quarter · Q3
H.R. 3167, Playing Fair on Trade and Innovation Act: Provisions related to intellectual property H.R. 3803, Bipartisan Congressional Trade Priorities Act of 2014: Provisions related to trade agreements H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions S. 1900, Bipartisan Congressional Trade Priorities Act of 2014: Trade promotion authority issues Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues Turkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues China intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues Trade Promotion Authority policy issues Generalized System of Preferences policy issues Colombia biosimilars policy issues
H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence Protecting Integrity in Medicare Act of 2014 (no bill number): Provisions related to addressing fraud, prescription drug abuse, and other issues Lock-in concepts generally
H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues
H.R. 3230, Veterans Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care program H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United State Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to Food and Drug Administration (FDA) funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security FY 2015 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Provisions related to 340B Drug Pricing Program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), Agency for Healthcare Research & Quality (AHQR) (no bill number) H.J. Res. 124, Continuing Appropriations Resolution
H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H,R, 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S.2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
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2014 · second_quarter · Q2
H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issuesH.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence
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2014 · first_quarter · Q1
FY 2015 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act: Provisions related to Food and Drug Administration (FDA) regulation and funding, sequestration, drug importation (no bill number) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reformFY 2015 Commerce, Justice, Science, and Related Agencies Appropriations Act: Provisions related to trade and prescription narcotics regulation (no bill number) FY 2015 Department of Homeland Security Appropriations Act: Provisions related to Customs and Border Control Agency funding, drug imports (no bill number) FY 2015 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Provisions related to 340B Drug Pricing Program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), Agency for Healthcare Research & Quality (AHQR) (no bill number) H.R. 3547, Consolidated Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation, trade and prescription narcotics regulation, Customs and Border Control Agency funding, 340B, NIH, IPAB and AHQR Issues related to user fee reauthorization and FDA reform
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2013 · fourth_quarter · Q4
H.R. 2674, 340B Program Improvement Act: Provisions related to 340B Drug Pricing Program (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain security H.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track productsH.R. 3204, Drug Quality and Security Act: Provisions related to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions related to drug compounding (112th Congress) H.R. 3742, Antibiotic Development to Advance Patient Treatment Act S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B Drug Pricing Program (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues Drug abuse policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B Drug Pricing Program policy issues
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2013 · third_quarter · Q3
H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues
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2013 · second_quarter · Q2
H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues
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2013 · first_quarter · Q1
H.Con.Res. 25, FY 2014 Budget Resolution H.Con.Res.112, House Budget Resolution: Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO Homeland Security, DOD, USTR)H.J.Res.117, Continuing Appropriations Act: Provisions related sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting H. 933, Consolidated and Further Continuing Appropriations Act, 2013: Provisions related sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting S.Con.Res. 8, FY 2014 Budget Resolution
H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues
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2012 · fourth_quarter · Q4
The Budget Control Act of 2011 (Public Law 112-25): Sequester implementation H.J. Res. 117, Continuing Appropriations Resolution, 2013: Provisions related to FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting
H.R. 6083, Federal Agriculture Reform and Risk Management Act of 2012: Provisions related to WTO Brazil cotton dispute H.R. 6156, Russia and Moldova Jackson-Vanik Repeal and Sergei Magnitsky Rule of Law Accountability Act of 2012: Trade relations provisions S. 3240, Agriculture Reform, Food, and Jobs Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3285, A bill to authorize the extension of nondiscriminatory treatment (normal trade relations treatment) to products of the Russian Federation Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations Turkey Market Access Issues India innovation and market access issues EU/US trade liberalizing agreement Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Anti-counterfeiting policy issues Biopharmaceutical innovation policy issues
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2012 · third_quarter · Q3
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues
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2012 · second_quarter · Q2
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues
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2012 · first_quarter · Q1
Korea Free Trade Agreement: Provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Russia Permanent Normal Trade Relations (PNTR) Turkey Market Access Issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions (no bill number) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions (no bill number) FY 2013 Budget Resolution: Health related provisions
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2011 · fourth_quarter · Q4
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction
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2011 · third_quarter · Q3
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2011 · second_quarter · Q2
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2011 · first_quarter · Q1
H.R. 1, Full-Year Continuing Appropriations Act, 2011: FDA funding and related matters FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals
H.R. 1065, Pill Mill Crackdown Act of 2011: prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: prescription drug abuse S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: FDA and product liability issues S. 296, Preserving Access to Life-Saving Medications Act: prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: prescription drug abuse Health care reform implementation issues including health reform fee and essential benefits General FDA advocacy Biopharmaceutical innovation policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2010 · fourth_quarter · Q4
H.R. 3082, Continuing Appropriations Amendments, 2011: FDA funding, comparative effectiveness funding, importation policy rider, Biomedical Advanced Research and Development Authority (BARDA), trade and intellectual property restrictions, patent settlements
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 4954, To amend title 35, United States Code, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings: false patent marking H.R. 5980, Bring Jobs Back to America: Strategic Manufacturing & Job Repatriation Act: publication of patent applications and the economy H.R. 6352, Patent Lawsuit Reform Act of 2010: false patent marking H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 1315, Drug Price Competition Act of 2009: 180-day exclusivity issues S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property policy issues Biopharmaceutical innovation policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2010 · third_quarter · Q3
H.R. 3012, Trade Reform, Accountability, Development, and Employment Act of 2009 (TRADE Act of 2009): trade agreements Korea Free Trade Agreement: intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues Special 301 submission Preference Program Reform International market access and intellectual property issues Trade enforcement issues
H.RES. 1493, Providing for budget enforcement for fiscal year 2011: budget provisions S. 3606, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2011: FDA funding
H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, DEA regulation and related issuesH.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Secretary of Health and Human Services nomination Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H,R, 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S.2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues Draft legislation on demand letters Issues related to biopharmaceutical economic incentives and intellectual property
H.R. 3230, Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care programH.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United States Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to Food and Drug Administration (FDA) funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security FY 2015 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Provisions related to 340B Drug Pricing Program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), Agency for Healthcare Research & Quality (AHRQ) (no bill number)
H.R. 3167, Playing Fair on Trade and Innovation Act: Provisions related to intellectual property H.R. 3803, Bipartisan Congressional Trade Priorities Act of 2014: Provisions related to trade agreements H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions S. 1900, Bipartisan Congressional Trade Priorities Act of 2014: Trade promotion authority issuesKorea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues Turkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues China intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues Trade Promotion Authority policy issues Generalized System of Preferences policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 3742, Antibiotic Development to Advance Patient Treatment Act of 2013: Provisions related to antibiotics and drug approval H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013: Provisions related to the Controlled Substances Act, DEA regulation and related issuesS. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Quality, Security, and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013 H.R. 3116, MODDERN Cures Act of 2013 H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act of 2013: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act of 2013: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act of 2013: Provisions related to patent litigation, demand letters and the patent system S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2146, Patent Fee Integrity Act: Patent fee diversion prohibition Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues
H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part DH.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
H.R. 3167, Playing Fair on Trade and Innovation Act: Provisions related to intellectual property H.R. 3830, Bipartisan Congressional Trade Priorities Act of 2014: Provisions related to trade agreements S. 1900, Bipartisan Congressional Trade Priorities Act of 2014: Trade promotion authority issues Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public healthTrans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues Turkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues China intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues Trade Promotion Authority policy issues Generalized System of Preferences policy issues
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients' Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issuesH.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to Sustainable Growth Rate (SGR) reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity for combination drugs H.R. 3116, MODDERN Cures Act of 2013: Provisions related to diagnostics and exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act of 2013: Provisions related to patent litigation and other reforms Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues
H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug importsH.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees H.R. 3547, Consolidated Appropriations Act: Provisions in the appropriations bills identified above H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25: Provisions related to sequestration
H.R. 3167, Playing Fair on Trade and Innovation Act: Provisions related to intellectual property Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issuesTurkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues Trade Promotion Authority issues
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25 H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importationH.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug imports H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees
Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issuesTurkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues
H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)
H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation H.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug importsH.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits Department of Defense Appropriations Act, 2014 [no bill number]: Provisions related to bio-defense
Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issuesTurkey Market Access Issues India innovation, IP and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues The Agriculture Reform, Food and Jobs Act of 2013/H.R. 1947, Federal Agriculture Reform and Risk Management Act of 2013: Issues related to World Trade Organization (WTO) Brazil Cotton dispute Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues International market access and intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues in context of invitation to join TPP negotiationsTurkey Market Access Issues India innovation and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)
H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 6083, Federal Agriculture Reform and Risk Management Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3240, Agriculture Reform, Food, and Jobs Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3285, A bill to authorize the extension of nondiscriminatory treatment (normal trade relations treatment) to products of the Russian Federation Intellectual Property Attache Act: Provisions related to the government intellectual property attache program [no bill number] Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations Turkey market access issues India innovation and market access issues EU/US trade liberalizing agreement Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 2693, Budget Control Act of 2011: Sequestration implementation H.R. 5856, Department of Defense Appropriations Act, 2013: Provisions related to defense health accounts, biodefense funding/projects, and defense contracting H.J.Res. 117, Continuing Appropriations Resolution, 2013 FY 2013 Labor, Health and Human Services, and Education Appropriations bill [no bill number]: Provisions related to comparative effectiveness research, NIH funding, BARDA funding, ACA implementation funding, 340B, IPAB
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 6083, Federal Agriculture Reform and Risk Management Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3240, Agriculture Reform, Food, and Jobs Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3285, A bill to authorize the extension of nondiscriminatory treatment (normal trade relations treatment) to products of the Russian Federation Intellectual Property Attache Act: Provisions related to the government intellectual property attache program [no bill number] Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations Turkey Market Access Issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
H.R. 4966, Sequester Replacement Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy changes H.R. 5652, Sequester Replacement Reconciliation Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy change H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions H. 5326, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse H. 5855, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders S. 2323, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse S. 2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions S. 3216, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions [no bill number]
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012
H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues
H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues
Korea Free Trade Agreement: Provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Russia Permanent Normal Trade Relations (PNTR) Turkey Market Access Issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues
Korea Free Trade Agreement: Provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property and innovation issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2276, To require the Director of the United States Patent and Trademark Office to conduct a study on effective ways to provide confirming genetic diagnostic test activity where gene patents and exclusive licensing exist, and for other purposes: gene patent study provisions S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 1, Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH H.R. 1473, Department of Defense and Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2219, Department of Defense Appropriations Act, 2012: Provisions relating to various health accounts FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals
H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues
H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Korea Free Trade Agreement: Provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property issues Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Korea Free Trade Agreement: intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues Special 301 submission issues Preference Program Reform International market access and intellectual property issues Biopharmaceutical innovation policy issues
H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues
H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues
Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues
H.R. 3012, Trade Reform, Accountability, Development, and Employment Act of 2009 (TRADE Act of 2009): trade agreements Korea Free Trade Agreement: intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues Special 301 submission Preference Program Reform International market access and intellectual property issues
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4994: Medicare and Medicaid Extenders Act of 2010: exclusion issues H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act of 2010: exclusion issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
H.R. 1586, FAA Air Transportation Modernization and Safety Improvements: AMP issues H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: average manufacturer price (AMP) issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: AMP issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office