3.0.0 5334 2023-01-11T13:23:02Z 2023-01-11T13:23:02Z House H HR 2012-05-07 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BILBRAY:H.R. 5334.Congress has the power to enact this legislation pursuantto the following:Article I Section 8 Clause 18 of the U.S. Constitutionwhich reads that Congress has the power ``To make all Lawswhich shall be necessary and proper for carrying intoExecution the foregoing Powers, and all other Powers vestedby this Constitution in the Government of the United States,or in any Department or Officer thereof.''[Page H2321]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-05-11T18:43:30Z Referred to 2012-05-07T18:17:00Z 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 Advancing Breakthrough Therapies for Patients Act of 2012 112 2236 S 2012-03-26 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Food and Drug Administration Safety and Innovation Act 112 2516 S 2012-05-07 Placed on Senate Legislative Calendar under General Orders. Calendar No. 389. Related bill CRS Food and Drug Administration Safety and Innovation Act 112 3187 S 2012-07-09 Became Public Law No: 112-144. Related bill CRS 2012-05-11 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-05-07 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-05-07 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-05-07 Introduced in House IntroReferral 1000 9 Library of Congress B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 N D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2012-05-07 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health 00 2012-05-07 Introduced in House 2012-07-03T19:10:32Z 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 drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval.

Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations.

Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

]]> To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. Display Title To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. Official Title as Introduced To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. Introduced in House IH Introduced in House 2012-05-07T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr5334ih/xml/BILLS-112hr5334ih.xml 2012-05-11 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.