3.0.0 790 2023-01-11T13:28:33Z 2023-01-11T13:28:33Z House HR 2015-02-05 114 [Congressional Record Volume 161, Number 20 (Thursday, February 5, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 790.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8 of the United StatesConstitution.[Page H857]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-02-06T18:54:44Z Referred to 2015-02-05T14:05:35Z 2015-02-06 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-02-05 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-02-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-02-05 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N H001051 Rep. Hanna, Richard L. [R-NY-22] Richard Hanna R NY L. 22 2015-02-05 True B001290 Rep. Brat, Dave [R-VA-7] Dave Brat R VA 7 2015-06-24 False P000598 Rep. Polis, Jared [D-CO-2] Jared Polis D CO 2 2016-01-13 False B001274 Rep. Brooks, Mo [R-AL-5] Mo Brooks R AL 5 2016-02-01 False Health Business records Civil actions and liability Drug safety, medical device, and laboratory regulation Drug therapy Health technology, devices, supplies Long-term, rehabilitative, and terminal care Prescription drugs Retail and wholesale trades Trade restrictions Health 00 2015-02-05 Introduced in House 2015-08-10T18:07:09Z Compassionate Freedom of Choice Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

The FDA is prohibited from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device is not liable under state or federal law for loss, damage, or injury from: (1) the development, testing, production, acquisition, or use of such drugs or devices; or (2) their safety or effectiveness.

]]> Compassionate Freedom of Choice Act of 2015 Display Title Compassionate Freedom of Choice Act of 2015 Official Title as Introduced To allow the manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document, and for other purposes. Introduced in House IH Short Titles as Introduced Compassionate Freedom of Choice Act of 2015 Introduced in House 2015-02-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr790ih/xml/BILLS-114hr790ih.xml 2015-02-06 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.