H.R. 1165 would amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs, and to establish whistleblower protections for certain individuals.
Detailed Summary
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.
Status of the Legislation
Latest Major Action: 2/27/2007: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.
Points in Favor
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Points Against
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Visitor Comments
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May 22, 2007, 6:50pm (report abuse)Just another ploy of large pharmacuticals to capture the market and charge more money.