4390 -- Accelerated Approval Transparency Act | Poliscope

Accelerated Approval Transparency Act

4390

117th Congress

Health

In Committee

Legislative Progress

✓

Introduced

Committee

Floor Vote

Other Chamber

Enacted

Introduced

June 14, 2022

Latest Action

June 14, 2022

Primary Sponsor

John W. HickenlooperDemocratic(CO)

Momentum (last 30 days)

score

0 actions · 0 new cosponsors · 0 votes

Speed vs cohort

0pct

0d open

vs 5,357 other S bills in the 117th — cohort avg 38d

Summary

Accelerated Approval Transparency Act This bill requires the Food and Drug Administration to include a summary of the reasons a drug or biologic received accelerated approval to treat a serious or life-threatening disease or condition in the public action package for the drug or biologic.

Lobbying filings that explicitly cite this bill (1)

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 (1)

COVINGTON & BURLING LLP (1)

PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INCclient→COVINGTON & BURLING LLP

2022 · second_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

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).