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SAFE Drug Act

Introduced: February 16, 2007 Introduced by: Markey, Edward J. Democratic · Massachusetts See on congress.gov
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 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 27, 2007
Referred to the Subcommittee on Health.
Feb 17, 2007
Sponsor introductory remarks on measure. (CR E390-391)
Feb 16, 2007
Introduced in House
Feb 16, 2007
Referred to the House Committee on Energy and Commerce.
 Plain-English summary Congressional Research Service

Swift Approval, Full Evaluation Drug Act or the SAFE Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to: (1) order postmarket studies of approved drugs upon receiving evidence of a significant issue regarding the safety or lack of effectiveness of such a drug; and (2) establish restrictions on the distribution or use of the drug during the period in which the study is conducted.

Directs the Secretary to amend regulations to require postmarket studies of drugs approved under an accelerated approval process for new drugs for serious or life-threatening illnesses.

Deems a drug or device to be misbranded if there is a failure to comply with requirements under this Act.

Prohibits discrimination against individuals who provide information in an investigation or proceeding regarding a violation of any law, rule, or regulation, censorship, distortion, or suppression of scientific information, research, or analysis, or the willful disclosure of false, misleading, or incomplete scientific information.

Authorizes Food and Drug Administration (FDA) officers, employees, and sponsored individuals to publish in peer-reviewed journals and other scientific publications and make oral presentations at professional society meetings and other meetings of their peers, with certain exceptions.

Prohibits an FDA officer or employee from directing any other FDA officer or employee to: (1) censor, distort, or suppress any scientific research, analysis, opinion, or recommendation; or (2) willfully disclose scientific information that is false, misleading, or incomplete.

Requires the Secretary to publish a summary statement of the scientific basis for approval of any new drug and how the final decision balanced the risk and benefits within 48 hours after approval of an application.

What's happening now February 27, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2