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HR 6431 117th Congress House

Data Transparency and Drug Safety Act of 2022

Official title: To amend the Federal Food, Drug, and Cosmetic Act to prohibit the alteration, falsification, fabrication, destruction, omission, or removal of records or certa… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act to prohibit the alteration, falsification, fabrication, destruction, omission, or removal of records or certain information required to be produced or maintained for a drug, and for other purposes.

Introduced: January 19, 2022 Introduced by: Schrier, Kim Democratic · Washington See on congress.gov
Health
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 20, 2022
Referred to the Subcommittee on Health.
Jan 19, 2022
Introduced in House
Jan 19, 2022
Referred to the House Committee on Energy and Commerce.
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 Latest action January 20, 2022

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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 text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Republican 1
R
Joyce, John
Pennsylvania · Jan 19, 2022
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 6431: Data Transparency and Drug Safety Act of 2022. 117th Congress. Open America. https://openamerica.io/bill/117-HR-6431/
MLA
"H.R. 6431: Data Transparency and Drug Safety Act of 2022." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-6431/.
Bluebook (legal)
H.R. 6431, 117th Cong. (2026), https://openamerica.io/bill/117-HR-6431/.
Markdown link
[H.R. 6431: Data Transparency and Drug Safety Act of 2022](https://openamerica.io/bill/117-HR-6431/)
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