PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Jul 27, 2006
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.
People & committees
Rep. Markey, Edward J. [D-MA-7] · D–MA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR E1569-1570)
Introduced in House
Introduced in House
Primary sources
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No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 15, 2025. Consult Congress.gov for the current record.
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