3.0.0 2236 2020-02-10T17:00:02Z 2020-02-10T17:00:02Z Senate S S 2012-03-26 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2012-03-26T22:30:37Z To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. 112 5334 HR 2012-05-11 Referred to the Subcommittee on Health. 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 2012-03-26 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2012-03-26 Introduced in Senate IntroReferral 10000 9 Library of Congress B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO N H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT 2012-03-26 True B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2012-03-26 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Health 00 2012-03-26 Introduced in Senate 2012-05-14T17:02:48Z Advancing Breakthrough Therapies for Patients Act of 2012 - 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.

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

Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

]]> Advancing Breakthrough Therapies for Patients Act of 2012 Short Titles as Introduced Advancing Breakthrough Therapies for Patients Act of 2012 Display Title Advancing Breakthrough Therapies for Patients Act of 2012 Official Title as Introduced A bill to provide for the expedited development and evaluation of drugs designated as breakthrough drugs. Introduced in Senate 2012-03-26T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s2236is/xml/BILLS-112s2236is.xml 2012-03-26 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.