HR 909 — Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement Act

1 sponsors · 0 co-sponsors · 546 not signed on

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Frequently asked questions

What does HR 909 do?

Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement 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 Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.

Who sponsors HR 909?

HR 909 is sponsored by Michael McCaul (R).

What is the current status of HR 909?

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

Where can I track HR 909?

Track HR 909 free on One Click Politics — get push/email alerts when it moves.