legislation: 113-hr-5805

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bill_id congress bill_type bill_number title policy_area introduced_date latest_action_date latest_action_text origin_chamber sponsor_name sponsor_state sponsor_party sponsor_bioguide_id cosponsor_count summary_text update_date url
113-hr-5805 113 hr 5805 Andrea Sloan CURE Act Health 2014-12-08 2014-12-12 Referred to the Subcommittee on Health. House Rep. McCaul, Michael T. [R-TX-10] TX R M001157 0 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 Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO. 2023-01-11T13:25:14Z  

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