Andrea Sloan CURE Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Feb 12, 2015)
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Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.What just happenedFeb 13, 2015
Referred to the Subcommittee on Health.
Who’s behind it
- Introduced in HouseFeb 12, 2015
- Feb 13, 2015Committee
Referred to the Subcommittee on Health.
Health Subcommittee - Feb 12, 2015IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - Feb 12, 2015IntroReferralIntro-H
Introduced in House
- Feb 12, 2015IntroReferral1000
Introduced in House