SAFE Drug Act
Latest action · Feb 27, 2007 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 16, 2007
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on May 9, 2007.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Anna G. Eshoo | May 9, 2007 |
Actions 4
Everything that happened, newest first.
- Feb 27, 2007Referred to the Subcommittee on Health.
- Feb 17, 2007Sponsor introductory remarks on measure. (CR E390-391)
- Feb 16, 2007Introduced in House
- Feb 16, 2007Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative remedies
- Censorship
- Civil actions and liability
- Civil Rights and Liberties, Minority Issues
- Commerce
- Communication in medicine
- Communication in science
- Congressional reporting requirements
- Crime and Law Enforcement
- Criminal justice information
- 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
- Economics and Public Finance
- Federal advisory bodies
- Federal employees
- Federal officials
- Fines (Penalties)
- Food and Drug Administration (FDA)
- Fraud
- Government contractors
- Government Operations and Politics
- Government publicity
- Health
- Informed consent (Medical law)
- Labeling
- Labor and Employment
- Law
- Legal fees
- Marketing
- Misconduct in office
- Pharmaceutical research
- Punitive damages
- Risk
- Science, Technology, Communications
- Scientists in government
- Subcontractors
- Wage restitution
- Waste in government spending
- Whistle blowing
Text 1
Each version as it was printed, newest first.
- Feb 16, 2007Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.
