3.0.0 5805 2023-01-11T13:25:14Z 2023-01-11T13:25:14Z House H HR 2014-12-08 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. McCAUL:H.R. 5805.Congress has the power to enact this legislation pursuantto the following:Article I, Sec. 8: ``The Congress shall have Power To . . .regulate Commerce . . . among the several States . . .''[Page H8868]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2014-12-12T20:36:03Z Referred to 2014-12-08T17:00:50Z 2014-12-12 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2014-12-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-12-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-12-08 Introduced in House IntroReferral 1000 9 Library of Congress M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 N Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Congressional oversight Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Government information and archives Government studies and investigations Health care coverage and access Health 00 2014-12-08 Introduced in House 2015-02-24T22:21:28Z Andrea Sloan Compassionate Use Reform and Enhancement Act or the Andrea Sloan CURE Act - Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of a “breakthrough drug” (which is a drug that qualifies for expedited approval, is an infectious disease product, or qualifies the sponsor for a priority review voucher) to submit to the Secretary of Health and Human Services (HHS) and make available to the public a policy on requests for access to the drug for compassionate use, including the minimum criteria for consideration or approval of requests and the time needed to make a decision.

Requires a breakthrough drug sponsor to explain a denied request for compassionate use to the person who made the request.

Directs HHS to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access.

Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.]]> Andrea Sloan CURE Act Display Title Andrea Sloan CURE Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to expanding access for breakthrough drugs, and for other purposes. Introduced in House IH Short Titles as Introduced Andrea Sloan CURE Act Short Titles as Introduced Andrea Sloan Compassionate Use Reform and Enhancement Act Introduced in House 2014-12-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr5805ih/xml/BILLS-113hr5805ih.xml 2014-12-12 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.