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Legislative Progress
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43pct
1d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (6)
2024 · fourth_quarter · Medicare/Medicaid
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Funding for SUNY Downstate hospital Opposing potential cuts to Medicaid H.R.9351, Save our Safety-Net Hospitals Act Monitor the following: Medicaid funding generally H.R.7513/S.3410, Protecting Americas Seniors Access to Care Act, Safe nurse staffing standard. Funding for Medicare low-income outreach and enrollment efforts H.R.3761/S.1774, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicaid funding in schools Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Client expense: Not reported · Firm income: $200,000
Government targets: SENATE
2024 · third_quarter · Medicare/Medicaid
Funding for SUNY Downstate hospital Monitor the following: Medicaid funding generally H.R.7513/S.3410, Protecting Americas Seniors Access to Care Act, Safe nurse staffing standard. Medicare Advantage and US territories Medicare Program: Appeal Rights for Certain Changes in Patient Status (CMS-4204-P) Funding for Medicare low-income outreach and enrollment efforts H.R.6004/S.3090, the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicaid funding in schools Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Medicare/Medicaid
Medicaid funding generally Monitor the following: H.R.7513/S.3410, Protecting Americas Seniors Access to Care Act, Safe nurse staffing standard. Medicare Advantage and US territories Medicare Program: Appeal Rights for Certain Changes in Patient Status (CMS-4204-P) Funding for Medicare low-income outreach and enrollment efforts H.R.6004/S.3090, the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicaid funding in schools Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $280,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES
2024 · first_quarter · Medicare/Medicaid
H.R.7513/S.3410, Protecting Americas Seniors Access to Care Act, Safe nurse staffing standard. Monitor the following Medicare Advantage and US territories Medicare Program: Appeal Rights for Certain Changes in Patient Status (CMS-4204-P) Funding for Medicare low-income outreach and enrollment efforts H.R.6004/S.3090, the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act Medicaid funding H.R.3761/S.1774, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicaid funding in schools Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES
2023 · fourth_quarter · Medicare/Medicaid
Funding for Medicare low-income outreach and enrollment efforts H.R.6004/S.3090, the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act Monitor the following Medicaid funding H.R.3761/S.1774, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicare for America Act, Entirety Medicaid funding in schools Medicaid changes post-COVID pandemic Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · fourth_quarter · Health Issues
Public Law 111-148, Affordable Care Act, Section 1557 rule implementation ACCESS in Mental Health Act (draft bill) Mental Health CARE Act (draft bill) Supporting All Students Act (draft bill) Epi-pen Price Cap legislation, (draft bill) Funding for Medicare low-income outreach and enrollment efforts H.R.5894/S.2624, Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes, FY2024, Opposing restrictions on reproductive rights H.R.4368/S.2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2024, Protect access to Mifepristone H.R.6251, the Helping Educators Respond to Overdoses Act, H.R. 4771, the Childrens Health Insurance Program Permanency Act Seizure Awareness and Preparedness Act (draft bill) S.3090/H.R.6004, the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act H.R.4775, The Helping Tobacco Users Quit Act Prevention and Public Health Fund related issues H.R.6204, the See the Board Act Requirements Related to the Mental Health Parity and Addiction Equity Act, File Code 1210-AC11 Public Law 118-31, National Defense Authorization Act for Fiscal Year 2024, Teacher healthcare coverage; and Monitor World Trade Center Health Program S.1409, Kids Online Safety Act, Entirety Monitor the following: Proposed regulation: File Code 1210-AC11, Requirements Related to the Mental Health Parity and Addiction Equity Act Safe staffing levels at nursing homes H.R. 5625, the Fentanyl Awareness for Children and Teens in Schools H.R.4771, the Childrens Health Insurance Program Permanency Act Affordable Drug Manufacturing Act, not introduced S.2530, the Mental Health of Educators and Staff Act Primary Care and Health Workforce Expansion Act (draft bill) H.R. 4774, the Helping Tobacco Users Quit Act Medicare drug negotiation program PMB reform H.R.5378, the Lower Costs, More Transparency Act Reauthorization of healthcare workforce programs S.2333, Pandemic and All-Hazards Preparedness and Response Act S.1113, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act Appropriations regarding but not limited to community violence intervention, the CDCs Office on Smoking and Health (OSH), School-Based Mental Health Services Professional Demonstration Grants/ School-Based Mental Health Services Grant Program, gun violence prevent and removing abortion prohibition language from future appropriations bills. H.R.3727 Teacher Health and Wellness Act S.1446, Nurse Corps Tax Parity Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act H.R.3726, Student Mental Health Rights Act H.R.3305, Black Maternal Health Momnibus Act Funding for CDCs Social Determinants of Health program H.R.3646, Menstrual Equity for All Act of 2023, Incarceration related issues H.R.3682, Cady Housh and Gemesha Thomas Student Suicide Prevention Act of 2023, Entirety Public Law 117-169, Inflation Reduction Act, Prescription drug reform Public Law 117-159, Bipartisan Safer Communities Act Medicaid DSH Payments, Hospital funding formula Abortion Access related issues Supporting Trauma Informed Education Practices Act Restoring Hope for Mental Health and Well‐Being Act Nurse Overtime and Patient Safety Act Health Force and Resilience Force Act Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Telehealth issues Medicare X Choice Act Rural Healthcare related issues and initiatives H.R.12/S.701, the Women's Health Protection Act, Entirety Mental health supports for educators Closing Health Coverage Gaps for Public Servants Act Workplace Violence Prevention for Health Care and Social Service Worker Act Visas for international healthcare professionals Dobbs vs Jackson, United States Supreme Court decision Workplace violence related issues Green New Deal for Health, Entirety H.R.1485/S.727, Insulin for All Act H.R.1692, Health Care Affordability Act S.1139 A bill to apply prescription drug inflation rebates to drugs furnished in the commercial market Minimum staffing levels in skilled nursing facilities related issues Health Worker Shortage/Staffing Crisis
2023 · third_quarter · Medicare/Medicaid
Medicaid Funding Monitor the following: S.1774/H.R. 3761, Advancing Student Services in Schools Today Act Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicare for America Act, Entirety Medicaid funding in schools Medicaid changes post-COVID pandemic Medicare Advantage Physician reimbursement rates Site neutral payment proposals
Client expense: $250,000 · Firm income: Not reported
Government targets: Education, Dept of
2023 · third_quarter · Health Issues
Primary Care and Health Workforce Expansion Act, draft bill H.R. 4774, the Helping Tobacco Users Quit Act Medicare drug negotiation program H.R.2670/S.2226, National Defense Authorization Act for Fiscal Year 2024, World Trade Center Health Program Proposed regulation: File Code 1210-AC11, Requirements Related to the Mental Health Parity and Addiction Equity Act Safe staffing levels at nursing homes H.R. 5625, the Fentanyl Awareness for Children and Teens in Schools H.R.4771, the Childrens Health Insurance Program Permanency Act S.1409, Kids Online Safety Act, Entirety Affordable Drug Manufacturing Act, not introduced S.2530, the Mental Health of Educators and Staff Act Monitor the following: PMB reform H.R.5378, the Lower Costs, More Transparency Act Reauthorization of healthcare workforce programs S.2333, Pandemic and All-Hazards Preparedness and Response Act S.1113, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act Appropriations regarding but not limited to community violence intervention, the CDCs Office on Smoking and Health (OSH), School-Based Mental Health Services Professional Demonstration Grants/ School-Based Mental Health Services Grant Program, gun violence prevent and removing abortion prohibition language from future appropriations bills. H.R.3727 Teacher Health and Wellness Act S.1446, Nurse Corps Tax Parity Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act H.R.3726, Student Mental Health Rights Act H.R.3305, Black Maternal Health Momnibus Act Funding for CDCs Social Determinants of Health program H.R.3646, Menstrual Equity for All Act of 2023, Incarceration related issues H.R.3682, Cady Housh and Gemesha Thomas Student Suicide Prevention Act of 2023, Entirety Public Law 117-169, Inflation Reduction Act, Prescription drug reform Public Law 117-159, Bipartisan Safer Communities Act Medicaid DSH Payments, Hospital funding formula Abortion Access related issues Supporting Trauma Informed Education Practices Act Restoring Hope for Mental Health and Well‐Being Act Nurse Overtime and Patient Safety Act Health Force and Resilience Force Act Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Telehealth issues Medicare X Choice Act Rural Healthcare related issues and initiatives H.R.12/S.701, the Women's Health Protection Act, Entirety Mental health supports for educators Closing Health Coverage Gaps for Public Servants Act Workplace Violence Prevention for Health Care and Social Service Worker Act Visas for international healthcare professionals Dobbs vs Jackson, United States Supreme Court decision Workplace violence related issues Green New Deal for Health, Entirety H.R.1485/S.727, Insulin for All Act H.R.1692, Health Care Affordability Act S.1139 A bill to apply prescription drug inflation rebates to drugs furnished in the commercial market Minimum staffing levels in skilled nursing facilities related issues Health Worker Shortage/Staffing Crisis
2023 · second_quarter · Education
1. Student loan relief provisions generally, including student loan payment pause; debt cancellation; and borrower defense to repayment discharges 2. H.J.Res.45/S.J.Res.22, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Education relating to Waivers and Modifications of Federal Student Loans 3.School Staff Workforce related issues including staff shortages, teacher diversity, teacher preparation and tutoring services, teacher apprenticeship 4.Paraprofessionals and teacher pay 5.School staff working conditions, pay, shortages, respect, benefits 6.Enforcement of program integrity rules and efforts to identify low-value programs (higher education), including gainful employment regulations 7.Climate Change Education, Entirety 8.DC voucher/SOAR FY2024 funding and policy provisions 9.Postsecondary Student Success Grants (College completion) and funding 10.Online program management companies, role in higher education and compliance with incentive compensation ban 11.Green Ribbon Schools Act, Entirety 12.Right to Read Act, Book Banning; and Academic Censorship related issues 13.Career and Technical Education related issues 14.Instructional spending metrics (institutions of higher education) 15.Community School related issues 16.S.385, Full Service Community Schools Expansion Act, Entirety 17.H.R.5, Parents Bill of Rights, Entirety 18.H.R.3727 Teacher Health and Wellness Act 19.S.1774/H.R. 3761, Advancing Student Services in Schools Today Act 20.H.R.3726, Student Mental Health Rights Act 21.H.R.2949/S.1331, PSLF Payment Completion Fairness Act 22.S.1353, Adjunct Faculty Loan Fairness Act of 2023 23.Possible changes to federal collection and dissemination of higher education data, including through reauthorization of Education Sciences Reform Act (ESRA) or other legislation 24.H.R.3596/S.1762, Protecting our Students in Schools Act of 2023 25.Student Loan Interest Elimination Act (draft bill) 26.Americas College Promise Act 27.College for All Act 28.Inform Parents Act (draft bill) 29.Isakson-Roe Education Oversight Expansion Act (draft bill) 30.H.R.3188, Teaching Asian Pacific American History Act, Entirety 31.H.R.3188, Teaching Asian Pacific American History Act, Entirety 32.The IDEA Full Funding Act 33.H.R.2715/S.1202, Keep Our Promise to America's Children and Teachers (PACT) Act 34.H.R.793/S.161, JOBS Act, Pell Grant issues 35.S.1409, Kids Online Safety Act, Entirety Monitor the following: 1.Public Law 117-169, Inflation Reduction Act, Broadband related issues; American Families Plan; 2.Education provisions; and Climate generally 3.Public Law 117-58, Infrastructure Investment and Jobs Act, Indoor Air Quality in Schools; 4.Public Law 117-200, Joint Consolidation Loan Separation Act 5.H.R.2728, Young Farmer Success Act 6.Public Service Loan Forgiveness (PSLF), Improvements and generally; Including PSLF waiver, regulations, and TEPSLF 7.Department of Education, Title IX and Sex-Related Eligibility Criteria for Male and Female Athletic Teams 8.Teacher loan forgiveness programs, generally 9.Electric Bus related issues 10.TEACH (Teacher Education Assistance for College and Higher Education) Grant program related issues, generally 11.Student Loan Servicing Reform and Consumer Protection related issues 12.Borrower defense rule issues 13.Public transparency for low financial-value postsecondary programs 14.Child Care and Pre-Kindergarten, generally 15.Child care workforce issues, generally 16.Recognizing Care Workers 17.Income-driven repayment plans (student loans), including Administrative adjustment, regulations, and generally 18.Keeping All Students Safe Act, Entirety 19.S.889, Protecting Students from Worthless Degrees Act 20.Accreditation (higher education) issues 21.School climate proposals, including Counseling Not Criminalization in Schools Act 22.Respond, Innovate, Succeed and Empower (RISE) Act
2023 · second_quarter · Medicare/Medicaid
Medicaid Funding S.1774/H.R. 3761, Advancing Student Services in Schools Today Act Monitor the following: Federal Medicaid Funding (FMAP) and the territories Public Law 117-169, Inflation Reduction Act, Prescription Drug related issues Medicaid DSH Payments, Hospital funding formula Medicare Negotiation and Competitive Licensing Act, Entirety Medicare for America Act, Entirety Medicaid funding in schools Medicaid changes post-COVID pandemic
Client expense: $390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
Health Worker Shortage/Staffing Crisis S.1113, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act Appropriations regarding but not limited to community violence intervention, the CDCs Office on Smoking and Health (OSH), School-Based Mental Health Services Professional Demonstration Grants/ School-Based Mental Health Services Grant Program, gun violence prevent and removing abortion prohibition language from future appropriations bills. H.R.3727 Teacher Health and Wellness Act S.1446, Nurse Corps Tax Parity Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act H.R.3726, Student Mental Health Rights Act H.R.3305, Black Maternal Health Momnibus Act Funding for CDCs Social Determinants of Health program H.R.3646, Menstrual Equity For All Act of 2023, Incarceration related issues H.R.3682, Cady Housh and Gemesha Thomas Student Suicide Prevention Act of 2023, Entirety S.1409, Kids Online Safety Act, Entirety Monitor the following: Public Law 117-169, Inflation Reduction Act, Prescription drug reform Public Law 117-159, Bipartisan Safer Communities Act Medicaid DSH Payments, Hospital funding formula Abortion Access related issues Supporting Trauma Informed Education Practices Act Restoring Hope for Mental Health and Well‐Being Act Nurse Overtime and Patient Safety Act Health Force and Resilience Force Act, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Telehealth issues Medicare X Choice Act Rural Healthcare related issues and initiatives H.R.12/S.701, the Women's Health Protection Act, Entirety Mental health supports for educators Closing Health Coverage Gaps for Public Servants Act Workplace Violence Prevention for Health Care and Social Service Worker Act Visas for international healthcare professionals Dobbs vs Jackson, United States Supreme Court decision Workplace violence related issues Green New Deal for Health, Entirety H.R.1485/S.727, Insulin for All Act H.R.1692, Health Care Affordability Act S.1139 A bill to apply prescription drug inflation rebates to drugs furnished in the commercial market Minimum staffing levels in skilled nursing facilities related issues
2022 · fourth_quarter · Health Issues
-Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. -CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. - Inflation Reduction Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; the establishment Advanced Research Projects Agency for Health (ARPA-H); provisions related to extending marketplace subsidies under the Patient Protection and Affordable Care Act; and provisions related to an out-of-pocket maximum for Medicare beneficiaries' prescription drugs. - Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19. - HELP Copays Act (H.R.5801) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs.
Client expense: $25,000 · Firm income: Not reported
2022 · fourth_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)
2022 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2022 · fourth_quarter · Health Issues
H. RES. 1330 H.R. 6216/S. 3389, the Sickle Cell Disease Comprehensive Care Act H.R. 8855/S. 4866, the Sickle Cell Disease Treatment Centers Act of 2022 S. 1644/H.R. 3761, the Promising Pathway Act S. 373/H.R. 4472, the BENEFIT Act of 2021 H.R.2623, Camerons Law
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property
2022 · third_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2022 · third_quarter · Health Issues
-Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. -CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. - Inflation Reduction Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; the establishment Advanced Research Projects Agency for Health (ARPA-H); provisions related to extending marketplace subsidies under the Patient Protection and Affordable Care Act; and provisions related to an out-of-pocket maximum for Medicare beneficiaries' prescription drugs. - Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19. - HELP Copays Act (H.R.5801) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs.
Client expense: $25,000 · Firm income: Not reported
2022 · second_quarter · Health Issues
H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022
2022 · second_quarter · Health Issues
H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2022 · second_quarter · Health Issues
-Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. -CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. - Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; the establishment Advanced Research Projects Agency for Health (ARPA-H); and provisions related to an out-of-pocket maximum for Medicare beneficiaries' prescription drugs. - Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare bill, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19. - HELP Copays Act (H.R.5801)-- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs.
Client expense: $25,000 · Firm income: Not reported
2022 · first_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform
2022 · first_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform
2022 · first_quarter · Health Issues
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction. -The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. -Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases. -Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. - Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; and the establishment Advanced Research Projects Agency for Health (ARPA-H). - Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare bill, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19. - ACT for ALS (P.L. 117-70) - Conversations surrounding implementation of PL 117-79, the Accessing Critical Therapies for ALS Act.
2022 · first_quarter · Health Issues
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2021 · fourth_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
2021 · fourth_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
2021 · fourth_quarter · Health Issues
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction. -The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. -Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases. -Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS. CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; and the establishment Advanced Research Projects Agency for Health (ARPA-H). Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare bill, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19.
2021 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
2021 · third_quarter · Health Issues
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction. -The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. -Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases. -Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS.
Client expense: $25,000 · Firm income: Not reported
2021 · third_quarter · Health Issues
H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3684: Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: Give Kids a Chance Act (RACE 2.0) - Provisions related to pediatric investigations S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients DSHEA 2.0 HSA/FSA eligibility for Dietary Supplements Quit because of COVID Act Provisions related to Medicare's noninterference clause 340B Drug Pricing Program Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. Con. Res. Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031. House of Representatives Build Back Better Act package- Rx and tax offset provisions Senate Build Back Better deliberations
2021 · third_quarter · Health Issues
H.R. 5: Equality Act H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2623: Camerons Law - Provisions related to orphan drugs H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2021 · second_quarter · Health Issues
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction. -The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. -Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases. -Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS.
Client expense: $25,000 · Firm income: Not reported
2021 · second_quarter · Health Issues
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction. -The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. -Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases. -Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS.
Client expense: $25,000 · Firm income: Not reported
| Democratic |
| CA |
| Jake Auchincloss | Democratic | MA |
| James P. McGovern | Democratic | MA |
| Lori Trahan | Democratic | MA |
| Mike Quigley | Democratic | IL |
| Vicky Hartzler | Republican | MO |
Client expense: $290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
Client expense: $250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE
Client expense: $390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $7,270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $6,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $830,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $25,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $8,070,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS)
Client expense: $1,000,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $25,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $7,160,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $7,440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE