Summary: H.R.5805 — 113th Congress (2013-2014)All Information (Except Text)

There is one summary for H.R.5805. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (12/08/2014)

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Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.