HR 6431 United States House · 117th Congress

Data Transparency and Drug Safety Act of 2022

Summary
Data Transparency and Drug Safety Act of 2022 This bill makes it a prohibited act under the Federal Food, Drug, and Cosmetic Act to destroy or falsify certain records pertaining to drugs regulated by the Food and Drug Administration (FDA). Specifically, the bill prohibits falsifying, destroying, omitting. or removing records or information that (1) must be produced during the development or manufacture of a drug, (2) must be produced in an application for FDA approval for a drug or maintained after a drug is approved, or (3) is subject to FDA inspection. A person (entity or individual) that violates this provision shall be subject to civil monetary penalties. The bill also provides for additional monetary penalties in instances where the violation is not sufficiently remedied after the responsible person has received written notice from the FDA of the violation.
Bill status in committee 1 of 4 stages cleared
Introduction
Jan 2022
Committee Review
Floor Vote
President
Introduced Jan 19, 2022 Last action Jan 20, 2022
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Full legislative history

Actions timeline

Total actions
3
Key actions
0
Committee
2
Jan 20, 2022
Committee
Referred to the Subcommittee on Health.
lower
Jan 19, 2022
Committee
Referred to the House Committee on Energy and Commerce.
lower
Jan 19, 2022
Introduced
Introduced in House
lower
1 primary · 1 co-sponsor

Sponsors