3.0.0 467 2023-01-11T20:04:22Z 2023-01-11T20:04:22Z Senate S S 2007-01-31 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-01-31T23:28:18Z 2007-01-31 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1449-1454) IntroReferral 2007-01-31 Introduced in Senate IntroReferral 10000 9 Library of Congress D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2007-01-31 True W000779 Sen. Wyden, Ron [D-OR] Ron Wyden D OR 2007-01-31 True B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2007-01-31 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2007-01-31 True H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD 2007-01-31 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2007-05-24 False J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2007-06-14 False Health Administrative procedure Auditing Cancer Chemotherapy Child health Clinical trials Commerce Communication in medicine Congress Congressional reporting requirements Data banks Department of Health and Human Services Drug advertising Drug approvals Drug industry Families Fines (Penalties) Government Operations and Politics Government paperwork Government publicity Governmental investigations Health information systems Identification devices Law Medical research Medical supplies National Institutes of Health (NIH) Nonprofit organizations Periodicals Product safety Research centers Science, Technology, Communications Social Welfare Health 00 2007-01-31 Introduced in Senate 2007-03-23T14:13:35Z Fair Access to Clinical Trials Act of 2007 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trial results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device.

Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug applications, including documentation of significant differences of opinion and the resolution of those differences; and (2) copies of written consultations on a drug's safety conducted by the Office of Surveillance and Epidemiology.

Requires the Secretary to assess civil monetary penalties for knowingly submitting inaccurate information to the FDA.

Allows the Secretary to correct any information included in the registry or database that is factually and substantively inaccurate, false, or misleading.

Extends requirements of this Act to clinical trials conducted outside of the United States under certain circumstances.

Prohibits a responsible person or a manufacturer from performing any act that prohibits, limits, or imposes unreasonable delays on the ability of an individual to discuss or publish the results of a clinical trial.

Requires the Secretary to enter into a contract with the Institute of Medicine to study the extent to which data submitted to the registry has impacted the public health.

]]> FACT Act Official Title as Introduced A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Introduced in Senate IS Display Title FACT Act Short Titles as Introduced FACT Act Short Titles as Introduced Fair Access to Clinical Trials Act of 2007 Introduced in Senate 2007-01-31T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s467is/xml/BILLS-110s467is.xml 2007-01-31 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1449-1454) 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.