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HR 5922 109th Congress House Health Administrative remedies Civil Rights and Liberties, Minority Issues Civil actions and liability Commerce Communication in science Congressional reporting requirements Damages Deceptive advertising Department of Health and Human Services Department of Labor Disciplining of employees Discrimination in employment Dismissal of employees Drug approvals Drug industry Drugs Federal employees Federal officials Fines (Penalties)

SAFE Drug Act

Introduced: July 27, 2006 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
Aug 1, 2006
Referred to the Subcommittee on Health.
Jul 27, 2006
Referred to the House Committee on Energy and Commerce.
Jul 27, 2006
Sponsor introductory remarks on measure. (CR E1569-1570)
Jul 27, 2006
Introduced in House
 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: (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.

What's happening now August 1, 2006

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2