3.0.0 4132 2023-01-11T13:23:00Z 2023-01-11T13:23:00Z House H HR 2012-03-05 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. STEARNS:H.R. 4132.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3, the power to regulateinterstate activity.[Page H1153]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-03-09T18:32:01Z Referred to 2012-03-05T17:04:20Z Food and Drug Administration Reform Act of 2012 112 5651 HR 2012-06-04 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420. Related bill CRS 2012-03-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-03-05 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-03-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-03-05 Introduced in House IntroReferral 1000 9 Library of Congress S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 N T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2012-03-05 True B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2012-03-06 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2012-03-19 False B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2012-03-22 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2012-04-16 False E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2012-04-16 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2012-04-17 False R000435 Rep. Ros-Lehtinen, Ileana [R-FL-18] ILEANA ROS-LEHTINEN R FL 18 2012-04-19 False P000258 Rep. Peterson, Collin C. [D-MN-7] COLLIN PETERSON D MN C. 7 2012-04-26 False R000593 Rep. Ross, Dennis A. [R-FL-12] Dennis Ross R FL A. 12 2012-04-26 False P000598 Rep. Polis, Jared [D-CO-2] Jared Polis D CO 2 2012-04-26 False P000599 Rep. Posey, Bill [R-FL-15] Bill Posey R FL 15 2012-04-26 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2012-04-26 False H001055 Rep. Heck, Joseph J. [R-NV-3] Joseph Heck R NV J. 3 2012-04-27 False D000613 Rep. Dold, Robert J. [R-IL-10] Robert Dold R IL J. 10 2012-04-27 False D000610 Rep. Deutch, Theodore E. [D-FL-19] Theodore Deutch D FL E. 19 2012-05-08 False H000324 Rep. Hastings, Alcee L. [D-FL-23] ALCEE HASTINGS D FL L. 23 2012-05-08 False P000585 Rep. Platts, Todd Russell [R-PA-19] TODD PLATTS R PA RUSSELL 19 2012-05-08 False P000583 Rep. Paul, Ron [R-TX-14] RON PAUL R TX 14 2012-05-09 False B001269 Rep. Barletta, Lou [R-PA-11] Lou Barletta R PA 11 2012-05-29 False H001062 Rep. Hochul, Kathleen C. [D-NY-26] Kathleen Hochul D NY C. 26 2012-06-08 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health 00 2012-03-05 Introduced in House 2012-05-23T14:52:01Z Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards.

Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition.

Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.

]]> FAST Act Display Title FAST Act Official Title as Introduced To amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedited approval of drugs for serious or life-threatening diseases or conditions. Introduced in House IH Short Titles as Introduced FAST Act Short Titles as Introduced Faster Access to Specialized Treatments Act Introduced in House 2012-03-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr4132ih/xml/BILLS-112hr4132ih.xml 2012-03-09 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.