Loading…
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
59pct
20d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Right to Try Act of 2015 Bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. Defines an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (3) is not approved, licensed, or cleared for commercial distribution under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (8)
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Congress.gov source codes: H11100, H11100-A
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · fourth_quarter · Pharmacy
Food and Drug Administration Safety and Innovation Act (FDASIA) implementation Issues and policies related to biosimilars exclusivity period Biosimilars FDA guidance Implementation of Drug Quality and Security Act Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S.2912, Trickett Wendler Right to Try Act of 2016 H.R. 3012, Right to Try Act of 2015
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program 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. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250 - DXM Abuse Prevention Act of 2015 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues 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 Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $492,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues 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 Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Medicare/Medicaid
Advocacy on biotechnology coverage, reimbursement issues, and Right To Try legislation, including S. 2192 and H.R. 3012
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 6, H.R. 34 & Public Law 114-255, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; S.3239, RACE for Children Act; Expanded Access (legislation not introduced) H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act; S. 2023, Prescription Drug Affordability Act of 2015; H.R. 6501, Prescription Drug and Medical Device Price Review Board Act of 2016; S.3455, Pharmaceutical Supply and Value Enhancement Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act (no legislation introduced);
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
H.R. 3012/S.2912 - 21st Centry Cures package and the "Right To Try." The need for federal agency guidance on how the Affordable Care Act treats graduate student healthcare plans.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 34 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit NIH Funding PDUFA MDUFA
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)
2016 · third_quarter · Health Issues
H.R. 6: 21ST CENTURY CURES ACT; PROVISIONS RELATED TO RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM H.R. 3012: RIGHT TO TRY ACT OF 2015; PROVISIONS RELATED TO THE RIGHT TO TRY H.R. 3742: ACCESS TO MARKETPLACE INSURANCE ACT; PROVISIONS RELATED TO PATIENT ASSISTANCE S 1767: COMBINATION PRODUCT REGULATORY FAIRNESS ACT OF 2016; PROVISIONS RELATED TO REGULATION OF COMBINATION PRODUCTS S 1878: ADVANCING HOPE ACT OF 2016; ALL PROVISIONS OF THE BILL S 2912: TRICKETT WENDLER RIGHT TO TRY ACT OF 2016; PROVISIONS RELATED TO RIGHT TO TRY
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Pharmacy
Food and Drug Administration Safety and Innovation Act (FDASIA) implementation Issues and policies related to biosimilars exclusivity period Biosimilars FDA guidance Implementation of Drug Quality and Security Act Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S.2912, Trickett Wendler Right to Try Act of 2016 H.R. 3012, Right to Try Act of 2015
Client expense: $270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - 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 - 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 - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
2016 · third_quarter · Health Issues
H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;
Client expense: $1,920,000 · Firm income: Not reported
2016 · third_quarter · Health Issues
H.R. 6 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) Funding for Pediatric Device Consortia Grant Program H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit Zika Funding CMS Medicare Part B Demonstration NIH Funding PDUFA
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)
2016 · second_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments 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 Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues 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 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 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
2016 · third_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues 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 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 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
2016 · third_quarter · Medicare/Medicaid
Advocacy on biotechnology coverage, reimbursement issues, and Right To Try legislation, including S. 2192 and H.R. 3012
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Pharmacy
Food and Drug Administration Safety and Innovation Act (FDASIA) implementation Issues and policies related to biosimilars exclusivity period Biosimilars FDA guidance Implementation of Drug Quality and Security Act Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S.2912, Trickett Wendler Right to Try Act of 2016 H.R. 3012, Right to Try Act of 2015
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health 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. 2055 - the Medical Countermeasure Innovation Act of 2015 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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - 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 - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - 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 - 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 - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)
2016 · second_quarter · Health Issues
H.R. 6 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 H.R. 1600 - Patients' Access to Treatments Act of 2015 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) Funding for Pediatric Device Consortia Grant Program H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act Zika Funding CMS Medicare Part B Demonstration
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)
2016 · second_quarter · Health 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 National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse 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 H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments 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 Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues 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 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 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
2016 · second_quarter · Health Issues
H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; Expanded Access to (draft legislation);
Client expense: $1,700,000 · Firm income: Not reported
| Republican |
| OH |
| Bruce Westerman | Republican | AR |
| Charles W. Boustany Jr. | Republican | LA |
| Chris Stewart | Republican | UT |
| Collin C. Peterson | Democratic | MN |
| Cynthia M. Lummis | Republican | WY |
| Dana Rohrabacher | Republican | CA |
| Darrell Issa | Republican | CA |
| Dave Brat | Republican | VA |
| David N. Cicilline | Democratic | RI |
| David P. Roe | Republican | TN |
| David Rouzer | Republican | NC |
| David Schweikert | Republican | AZ |
| Diane Black | Republican | TN |
| Doug LaMalfa | Republican | CA |
| Doug Lamborn | Republican | CO |
| Earl Blumenauer | Democratic | OR |
| F. James Sensenbrenner, Jr. | Republican | WI |
| Gary J. Palmer | Republican | AL |
| Glenn Grothman | Republican | WI |
| Grace Meng | Democratic | NY |
| J. French Hill | Republican | AR |
| Jody B. Hice | Republican | GA |
| Joe Barton | Republican | TX |
| Kevin Cramer | Republican | ND |
| Leonard Lance | Republican | NJ |
| Louie Gohmert | Republican | TX |
| Luke Messer | Republican | IN |
| Mark Meadows | Republican | NC |
| Mark Sanford | Republican | SC |
| Mark Walker | Republican | NC |
| Marlin A. Stutzman | Republican | IN |
| Martha McSally | Republican | AZ |
| Martha Roby | Republican | AL |
| Mia B. Love | Republican | UT |
| Michael G. Fitzpatrick | Republican | PA |
| Mick Mulvaney | Republican | SC |
| Mike Bishop | Republican | MI |
| Mike Coffman | Republican | CO |
| Mo Brooks | Republican | AL |
| Paul A. Gosar | Republican | AZ |
| Pete Olson | Republican | TX |
| Rick W. Allen | Republican | GA |
| Robert Pittenger | Republican | NC |
| Scott Garrett | Republican | NJ |
| Steve Cohen | Democratic | TN |
| Steve Israel | Democratic | NY |
| Steve King | Republican | IA |
| Steven M. Palazzo | Republican | MS |
| Ted S. Yoho | Republican | FL |
| Todd Rokita | Republican | IN |
| Todd Young | Republican | IN |
| Tom Graves | Republican | GA |
| Tom McClintock | Republican | CA |
| Tom Reed | Republican | NY |
| Trent Franks | Republican | AZ |
| Vicky Hartzler | Republican | MO |
| Zoe Lofgren | Democratic | CA |
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Client expense: $4,550,000 · Firm income: Not reported
Government 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), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Client expense: $4,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $5,820,000 · Firm income: Not reported
Government 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), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)