H.R. 6431 · 117th Congress
Data Transparency and Drug Safety Act of 2022
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
SchrierSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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).
What it does: CRS summary · Introduced in House · Jan 19, 2022
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Data Transparency and Drug Safety Act of 2022
Latest action (Jan 20, 2022): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jan 19, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.