3.0.0 1165 2023-01-11T20:02:13Z 2023-01-11T20:02:13Z House H HR 2007-02-16 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-02-27T20:25:21Z Referred to 2007-02-16T13:09:15Z 2007-02-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-02-17 Sponsor introductory remarks on measure. (CR E390-391) IntroReferral B00100 9 Library of Congress 2007-02-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-02-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-02-16 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2007-05-09 False Health 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 Health 00 2007-02-16 Introduced in House 2007-05-04T20:17:07Z 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.

]]> Swift Approval, Full Evaluation 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 Display Title Swift Approval, Full Evaluation Drug Act Short Titles as Introduced Swift Approval, Full Evaluation Drug Act Short Titles as Introduced SAFE Drug Act Introduced in House 2007-02-16T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1165ih/xml/BILLS-110hr1165ih.xml 2007-02-27 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.