Andrea Sloan CURE Act

Summary

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 an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving requests and the time needed to make a decision. Requires an investigational drug sponsor to explain a denied request for expanded access to the person who made the request. Directs the Department of Health and Human Services 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 Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 12 February 2015

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• Introduced in House (PDF)

  Introduced in House · EN · 12 February 2015

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• Introduced in House

  summary · EN · 12 February 2015

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