Swift Approval, Full Evaluation Drug Act

Bill: 110-hr-1165
Sponsor: Rep. Markey, Edward J. [D-MA-7]
Introduced: 2007-02-16 in the House
Policy area: Health
Subjects: Administrative remedies
Censorship
Civil Rights and Liberties, Minority Issues
Civil actions and liability
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 Operations and Politics
Government contractors
Government publicity
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

Summary:
action_date: 2007-02-16
text: 
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.


Legislative actions:
action_date: 2007-02-27
text: Referred to the Subcommittee on Health.
action_date: 2007-02-17
text: Sponsor introductory remarks on measure. (CR E390-391)
action_date: 2007-02-16
text: Referred to the House Committee on Energy and Commerce.
action_date: 2007-02-16
text: Introduced in House
action_date: 2007-02-16
text: Introduced in House