3.0.0 5922 2023-01-12T17:52:34Z 2023-01-12T17:52:34Z House H HR 2006-07-27 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2006-08-01T19:40:34Z Referred to 2006-07-27T14:06:35Z 2006-08-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2006-07-27 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2006-07-27 Sponsor introductory remarks on measure. (CR E1569-1570) IntroReferral B00100 9 Library of Congress 2006-07-27 Introduced in House IntroReferral Intro-H 9 Library of Congress 2006-07-27 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N 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) Food and Drug Administration (FDA) Government Operations and Politics Informed consent (Medical law) Labeling Labor and Employment Law Legal fees Marketing Pharmaceutical research Punitive damages Science, Technology, Communications Scientists in government Wage restitution Whistle blowing Health 00 2006-07-27 Introduced in House 2006-09-12T21:43:05Z 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.

]]> SAFE Drug Act Display Title SAFE Drug Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs, to establish whistleblower protections for certain individuals, and for other purposes. Introduced in House IH Short Titles as Introduced SAFE Drug Act Short Titles as Introduced Swift Approval, Full Evaluation Drug Act Introduced in House 2006-07-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109hr5922ih/xml/BILLS-109hr5922ih.xml 2006-08-01 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.