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United States · Bill · HR

H.R. 870 (109th)

PhRMA Act of 2005

referredUnited States· United States Congress· EN

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)

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