United States · Bill · HR
H.R. 870 (109th)
PhRMA Act of 2005
Introduced
16 February 2005
Last action
—
Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
15 August 2025
Summary
Pharmaceutical Research and Manufacturers Accountability Act of 2005 or the PhRMA Act of 2005 - Sets forth penalties for violations of acts prohibited under the Federal Food, Drug, and Cosmetic Act by an individual employed as the chief executive officer or as a member of the senior executive management group of the manufacturer of a drug, where the violation involves knowing concealment of evidence of a serious adverse drug experience. Requires the Secretary of Health and Human Services to require the chief executive officer of the manufacturer of a Food and Drug Administration (FDA)-approved drug to annually: (1) attest that the manufacturer has disclosed to the Secretary all evidence of any serious adverse drug experience related to the drug; and (2) describe the process by which the manufacturer ensures that such disclosure has occurred. Allows the Secretary to withdraw an approval for such a drug for failure to provide such an attestation. Prohibits a chief executive officer of a manufacturer of such a drug from failing to provide such an attestation. Requires the Secretary to direct a manufacturer or sponsor of a drug to complete any required postmarketing study of that drug by a specified deadline. Allows the Secretary to extend such a deadline. Sets forth penalties for failing to meet such a deadline.
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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 16 February 2005
Introduced in House (PDF)
Introduced in House · EN · 16 February 2005
Introduced in House
summary · EN · 16 February 2005
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/109th-congress/house-bill/870
- Open data entity: https://api.congress.gov/v3/bill/109/hr/870