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Andrea Sloan CURE Act

Introduced: February 12, 2015 Introduced by: McCaul, Michael T. Republican · Texas See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 13, 2015
Referred to the Subcommittee on Health.
Feb 12, 2015
Referred to the House Committee on Energy and Commerce.
Feb 12, 2015
Introduced in House
 Plain-English summary Congressional Research Service

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Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.
What's happening now February 13, 2015

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 4
All 4 Democratic 2 Republican 2