3.0.0 1020 2023-01-11T13:35:13Z 2023-01-11T13:35:13Z House HR 2017-02-13 115 [Congressional Record Volume 163, Number 25 (Monday, February 13, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 1020.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 H1126]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-02-17T17:34:16Z Referred to 2017-02-13T17:02:20Z 2017-02-17 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-02-13 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-02-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-02-13 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N B001290 Rep. Brat, Dave [R-VA-7] Dave Brat R VA 7 2017-02-13 True 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 2017-02-13 Introduced in House 2017-03-03T16:24:37Z Compassionate Freedom of Choice Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in that Act or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) may not prevent or restrict, the manufacture, importation, distribution, or sale of drugs or medical devices that are intended for terminally ill patients, have been the subject of a clinical trial, and have not been approved by the FDA.

The FDA may not require the disclosure, collection, or reporting of certain information concerning such drugs or devices. The sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Except in the case of gross negligence or willful misconduct, a person who manufactures, imports, distributes, prescribes, or administers such a drug or device is not liable under state or federal law for loss, damage, or injury from the development, testing, production, acquisition, use, safety, or effectiveness of the drug or device.

]]> Compassionate Freedom of Choice Act of 2017 Display Title Compassionate Freedom of Choice Act of 2017 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 2017 Introduced in House 2017-02-13T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr1020ih/xml/BILLS-115hr1020ih.xml 2017-02-17 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.