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PhRMA Act of 2005

Introduced: February 16, 2005 See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 14, 2005
Referred to the Subcommittee on Health.
Feb 16, 2005
Referred to the House Committee on Energy and Commerce.
Feb 16, 2005
Sponsor introductory remarks on measure. (CR E252)
Feb 16, 2005
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now March 14, 2005

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2