Modernizing the Accelerated Approval Pathway Act of 2022
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
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vs 5,357 other S bills in the 117th — cohort avg 38d
Modernizing the Accelerated Approval Pathway Act of 2022 This bill modifies provisions relating to the accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring the Food and Drug Administration (FDA) to publish its reasons when it determines a postapproval study to be unnecessary. The bill also establishes a pilot program and an FDA council to support the development of drugs for rare diseases and ensure the appropriate use of the accelerated approval pathway, respectively.
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 (4)
2022 · fourth_quarter · Health Issues
S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Initiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Inflation Reduction Act of 2022 (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act of 2022 (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S. 4260) NAPA Reauthorization Act (H.R. 7775/S. 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S. 4202) IMPROVE Nursing Homes Act (H.R. 8677) Kevin and Avonte's Reauthorization Act of 2022 (H.R. 8907/S. 4885) Modernizing Accelerated Approval Pathway Act (S. 4446) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127) Access to Innovative Treatments Act of 2022 (H.R. 9358) Consolidated Appropriations Act, 2023 (H.R. 2617) National Concussion Surveillance System (NCSS) funding at the CDC Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $490,000 · Firm income: Not reported
Government targets: Administration on Aging, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office
2022 · fourth_quarter · Health Issues
Issues related to prescription drug pricing, particularly as it relates to insulin S. 4446, Modernizing the Accelerated Approval Pathway Act of 2022 H.R. 6963, Accelerated Approval Integrity Act of 2022 H.R. 4128/S. 2209, VALID Act of 2021
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; Consolidated Appropriations Act, 2023 (PL 117-328), Division FF, Title III - Food and Drug Administration, Subtitle B - Drugs and Biologics and Subtitle F, Chapter 1 - Clinical Trial Diversity and Modernization; Package Inserts/eLabeling Issues (H.R. 7559 - Prescription Information Modernization Act of 2022).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to prescription drug pricing, particularly as it relates to insulin Issues related to coverage of preventive services Issues related to clinical trial diversity H.R.6963 - Accelerated Approval Integrity Act of 2022 S. 4446 - The Modernizing the Accelerated Approval Pathway Act of 2022 H.R. 3089/ S. 1544 - The Accelerating Kids Access to Care Act (AKACA) H.R. 6833/ S. 3700 - Affordable Insulin Now Act H.R. 7667 - Food and Drug Amendments of 2022 S. 4348 - FDASLA Act of 2022
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022.
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2022 · third_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; H.R. 6833 - The Continuing Resolution and Ukraine Supplemental Appropriations Act 2023, Division F - FDA User Fee Reauthorization Act of 2022; H.R. 7559 - the Prescription Information Modernization Act; Package Inserts/eLabeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R.7667); Build Back Better Act (H.R. 5376); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032) ; Abbreviated approval pathway for biologics; 180-day exclusivity; Cures 2.0 Act (H.R. 6000); Accelerated Approval Integrity Act of 2022 (H.R. 6963); Give Kids a Chance Act (S.4215, H.R. 6972); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Accelerating Access for Patients Act of 2022 (H.R. 6996); FDA Modernization Act of 2021 (H.R. 2565) ; PREVENT Pandemics Act (S. 3799) Simplifying the Generic Drug Application Process Act (S. 1462); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Accelerated Approval Transparency Act (S. 4390); Modernizing the Accelerated Approval Pathway Act of 2022 (S. 4446 ); Biologics Market Transparency Act of 2022 (H.R. 7035); Bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (H.R. 7649); Affordable Prescriptions for Patients Act of 2021 (S. 1435); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 2884); Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (H.R. 2873); Data Transparency and Drug Safety Act of 2022 (H.R. 6431).
Client expense: Not reported · Firm income: $510,000
2022 · second_quarter · Health Issues
H.R. 5585 - Advanced Research Projects Agency - Health H.R. 6000 - Cures 2.0 Act H.R. 6833 - Affordable Insulin Now Act H.R. 6963 - Accelerated Approval Integrity Act of 2022 H.R. 7667 - Food and Drug Amendments of 2022 Issues related to prescription drug pricing, particularly as it relates to insulin S. 3700 - Affordable Insulin Now Act S. 3819 - ARPA-H Act S. 4348 - FDASLA Act of 2022 S. 4446 - The Modernizing the Accelerated Approval Pathway Act of 2022
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022.
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2022 · second_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE