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Improving Regulatory Transparency for New Medical Therapies Act
Legislative Progress
Momentum (last 30 days)
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93pct
231d open
vs 3,548 other S bills in the 114th — cohort avg 43d
Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. (Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant. (Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
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.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · fourth_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6/H.R. 34 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R. 1151 - USPSTF Transparency and Accountability Act of 2015 H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5065/S. 3299 - Bottles and Breastfeeding Equipment Screening (BABES) Act H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 612 - Water Infrastructure Improvements for the Nation Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 2873/H.R. 5395 - Expanding Capacity for Health Outcomes (ECHO) Act S. 3136 - Improving Child Nutrition Integrity and Access Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016 S. 3504 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act
Client expense: Not reported · Firm income: $23,450
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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
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)
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Client expense: $890,000 · Firm income: Not reported
Government 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), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · first_quarter · Health Issues
H.R. 6, 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; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; 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); Public Law 113-54, Drug Quality & Security Act; 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;
Client expense: $2,610,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
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
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)
2016 · third_quarter · Health Issues
Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016
Client expense: Not reported · Firm income: $23,450
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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Client expense: $1,460,000 · Firm income: Not reported
Government 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), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848 - Water Resources Development Act of 2016
Client expense: Not reported · Firm income: $23,450
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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · second_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $200,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · first_quarter · Health Issues
H.R. 6, 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; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; 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); Public Law 113-54, Drug Quality & Security Act; 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;
Client expense: $2,600,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
H.R. 6, 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; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; 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); Public Law 113-54, Drug Quality & Security Act; 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;
Client expense: $26,000,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 270 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3379 - Airplane Kits Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act
Client expense: Not reported · Firm income: $23,450
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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · first_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 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 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) 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. 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 - the Medical Countermeasure Innovation Act of 2015 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development 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 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency 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. 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. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs 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. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs 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 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances 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 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 Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website 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 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 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 Generic Drug User Fee Act (GDUFA) policy 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 Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $1,490,000 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_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 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 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act of 2013 - Provisions related to orphan drug tax (113th Congress) 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. 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. 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. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development 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 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency 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. 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. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs 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. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs 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. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances 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 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 Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website 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 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 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 Generic Drug User Fee Act (GDUFA) policy 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 Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $5,950,000 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $160,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Client expense: $3,093,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · first_quarter · Health Issues
H.R. 6, 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; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; 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); Public Law 113-54, Drug Quality & Security Act; 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;
Client expense: $2,570,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
H.R. 6, 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; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; 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); Public Law 113-54, Drug Quality & Security Act; 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;
Client expense: $2,630,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Client expense: $3,150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2015 · second_quarter · Pharmacy
DEA scheduling of controlled substances H.R. 639/S 481 - Improving Regulatory Transparency for New Medical Therapies Act
Client expense: $510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Africa Health Systems Strengthening Health Information Technology HR 160 - Protect Medical Innovation Act of 2015 HR 2772 - Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016 HR 320 - Rapid DNA Act of 2015 HR 597 - Reform Exports and Expand the American Economy Act HR 639 - Improving Regulatory Transparency for New Medical Therapies Act HR 716 - Breast Density and Mammography Reporting Act of 2015 S 149 - Medical Device Access and Innovation Protection Act of 2015 S 370 - Breast Density and Mammography Reporting Act of 2015 S 481 - Improving Regulatory Transparency for New Medical Therapies Act S 819 - Export-Import Bank Reform and Reauthorization Act of 2015
Client expense: $4,100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2015 · third_quarter · Health Issues
S.1945 - Mental Health Reform Act of 2015, S.481 - Improving Regulatory Transparency for New Medical Therapies Act, S.1893 - Mental Health Awareness and Improvement Act of 2015, H.R.2624 - Helping Families in Mental Health Crisis Act of 2015
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · 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 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. 683: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research 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 S. 2055 - the Medical Countermeasure Innovation Act of 2015 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. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs 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. 1538: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research 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. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction 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. 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. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program 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. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act - Provisions related to amending and withdrawing funding from the Affordable Care Act 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 Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption 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 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 policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $380,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2015 · fourth_quarter · Health Issues
H.R. 2646, the Helping Families in Mental Health Crisis Act; H.R. 2690, Strengthening Mental Health In Our Communities Act; H.R. 6, 21st Century Cures initiative; S. 481, Improving Regulatory Transparency for New Medical Therapies Act
Client expense: Not reported · Firm income: $160,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 270 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017 - Common Sense Nutrition Disclosure Act H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3379 - Airplane Kits Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 4276 - Behavioral Health Coverage Transparency Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act
Client expense: Not reported · Firm income: $23,450
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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2015 · fourth_quarter · Pharmacy
ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes
Client expense: $510,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2015 · third_quarter · Health Issues
Africa Health Systems Strengthening Health Information Technology HR 160 - Protect Medical Innovation Act of 2015 HR 2772 - Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016 HR 320 - Rapid DNA Act of 2015 HR 597 - Reform Exports and Expand the American Economy Act HR 6 - 21st Century Cures HR 639 - Improving Regulatory Transparency for New Medical Therapies Act HR 716 - Breast Density and Mammography Reporting Act of 2015 Laboratory Developed Tests S 149 - Medical Device Access and Innovation Protection Act of 2015 S 370 - Breast Density and Mammography Reporting Act of 2015 S 481 - Improving Regulatory Transparency for New Medical Therapies Act S 819 - Export-Import Bank Reform and Reauthorization Act of 2015
Client expense: $3,470,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Health Issues
Africa Health Systems Strengthening Health Information Technology HR 160 - Protect Medical Innovation Act of 2015 HR 2772 - Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016 HR 320 - Rapid DNA Act of 2015 HR 597 - Reform Exports and Expand the American Economy Act HR 639 - Improving Regulatory Transparency for New Medical Therapies Act HR 716 - Breast Density and Mammography Reporting Act of 2015 S 149 - Medical Device Access and Innovation Protection Act of 2015 S 370 - Breast Density and Mammography Reporting Act of 2015 S 481 - Improving Regulatory Transparency for New Medical Therapies Act S 819 - Export-Import Bank Reform and Reauthorization Act of 2015
Client expense: $4,140,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2015 · fourth_quarter · Health Issues
S. 481: Improving Regulatory Transparency for New Medical Therapies Act, S. 1945: Mental Health Reform Act of 2015, S. 1893: Mental Health Awareness and Improvement Act of 2015, H.R. 2646: Helping Families in Mental Health Crisis Act of 2015
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
FDA and DEA regulation of cannabidiol; support of and technical changes to S. 481 (Improving Regulatory Transparency for New Medical Therapies Act); S. 1333 (Therapeutic Hemp Medical Access Act of 2015)
Client expense: Not reported · Firm income: $20,000
Government targets: SENATE
2015 · fourth_quarter · Pharmacy
DEA scheduling of controlled substances H.R. 639/S 481 - Improving Regulatory Transparency for New Medical Therapies Act (PL 114-89)
Client expense: $460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Discussions related to protected class reform, Essential Health Benefits Reform, Part D LIS co-pays H.R.9, Innovation Act 21st Century Cures S.481, Improving Regulatory Transparency for New Medical Therapies Act Mental health reform
Client expense: $320,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2015 · 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. 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. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research 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: 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. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs 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. 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. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research 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. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction 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. 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. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program 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. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act 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 Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption 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 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 policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $3,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2015 · fourth_quarter · Health Issues
H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies Act; Issues related to H.R. 6, The 21st Century Cures Act and Innovation Initiative.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Pharmacy
Ensure regulatory certainty for clinical trials and subsequent scheduling of FDA-approved medicines deemed to be controlled substances. HR 639/S 481, Improving Regulatory Transparency Act for New Medical Therapies Act
Client expense: $1,110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)
2015 · third_quarter · Health Issues
H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies Act; Issues related to H.R. 6, The 21st Century Cures Act and Innovation Initiative.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
S.1945 - Mental Health Reform Act of 2015, S.481 - Improving Regulatory Transparency for New Medical Therapies Act, S.1893 - Mental Health Awareness and Improvement Act of 2015, H.R.2624 - Helping Families in Mental Health Crisis Act of 2015
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
Discussions related to protected class reform, Essential Health Benefits Reform, Part D LIS co-pays H.R.9, Innovation Act 21st Century Cures S.481, Improving Regulatory Transparency for New Medical Therapies Act Mental health reform
Client expense: $340,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE