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<BillSummaries>
<item congress="113" measure-type="hr" measure-number="5805" measure-id="id113hr5805" originChamber="HOUSE" orig-publish-date="2014-12-08" update-date="2015-02-24">
<title>Andrea Sloan CURE Act</title>
<summary summary-id="id113hr5805v00" currentChamber="HOUSE" update-date="2015-02-24">
<action-date>2014-12-08</action-date>
<action-desc>Introduced in House</action-desc>
<summary-text><![CDATA[<p>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 &ldquo;breakthrough drug&rdquo; (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.</p> <p>Requires a breakthrough drug sponsor to explain a denied request for compassionate use to the person who made the request.</p> <p>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.</p> Directs HHS to finalize the draft guidance entitled &ldquo;Expanded Access to Investigational Drugs for Treatment Use--Qs &amp; As,&rdquo; taking into account reports from the Task Force and GAO.]]></summary-text>
</summary>
</item>
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<dc:language>EN</dc:language>
<dc:rights>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.</dc:rights>
<dc:contributor>Congressional Research Service, Library of Congress</dc:contributor>
<dc:description>This file contains bill summaries 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.</dc:description>
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