SAFE Drug Act

Summary

Swift Approval, Full Evaluation Drug Act or the SAFE Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to: (1) authorize the Secretary of Health and Human Services, upon receipt of evidence regarding the safety or lack of effectiveness of an approved drug, to order studies of such drug (postmarket studies) and place restrictions on the distribution or use of such drug during such studies; (2) require postmarket studies as a condition of approval of a new drug; (3) impose civil penalties for distributing misbranded or adulterated drugs or for failing to compete a required postmarket study; (4) label a drug misbranded if a drug manufacturer fails to make required postmarket labeling changes; (5) grant officers and employees of the Food and Drug Administration the right to publish or present data unless such data is subject to federal export control or national security laws or is proprietary information; and (6) require the Secretary to submit biennial reports to Congress on approved drug applications supported by non-inferiority studies and on postmarket studies. Extends protections to individuals (whistleblowers) who provide information of illegal activity to government officials.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 27 July 2006

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• Introduced in House (PDF)

  Introduced in House · EN · 27 July 2006

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• Introduced in House

  summary · EN · 27 July 2006

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