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H.R. 870 · 109th Congress

PhRMA Act of 2005

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Never voted on. It didn't reach a floor vote before the 109th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

PSD StarkSponsor
13 cosponsors · 12 D, 1 I

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…

What it does: CRS summary · Introduced in House · Feb 16, 2005

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: PhRMA Act of 2005

Also known as: Pharmaceutical Research and Manufacturers Accountability Act of 2005

Latest action (Mar 14, 2005): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Feb 16, 2005

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.