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Data Transparency and Drug Safety Act of 2022

USA117th CongressHR-6431| House 
| Updated: 1/20/2022
Kim Schrier

Kim Schrier

Democratic Representative

Washington

Cosponsors (1)
John Joyce (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 19, 2022
Introduced in House
Jan 19, 2022
Referred to the House Committee on Energy and Commerce.
Jan 20, 2022
Referred to the Subcommittee on Health.
  • January 19, 2022
    Introduced in House


  • January 19, 2022
    Referred to the House Committee on Energy and Commerce.


  • January 20, 2022
    Referred to the Subcommittee on Health.

Health

Data Transparency and Drug Safety Act of 2022

USA117th CongressHR-6431| House 
| Updated: 1/20/2022
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 19, 2022
Introduced in House
Jan 19, 2022
Referred to the House Committee on Energy and Commerce.
Jan 20, 2022
Referred to the Subcommittee on Health.
  • January 19, 2022
    Introduced in House


  • January 19, 2022
    Referred to the House Committee on Energy and Commerce.


  • January 20, 2022
    Referred to the Subcommittee on Health.
Kim Schrier

Kim Schrier

Democratic Representative

Washington

Cosponsors (1)
John Joyce (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted