H.R. 4132 (112th): FAST Act

Mar 05, 2012 (112th Congress, 2011–2013)
Died (Referred to Committee)
Clifford “Cliff” Stearns
Representative for Florida's 6th congressional district
Read Text »
Last Updated
Mar 05, 2012
12 pages
Related Bills
H.R. 5651 (Related)
Food and Drug Administration Reform Act of 2012

Passed House
Last Action: May 30, 2012


This bill was introduced on March 5, 2012, in a previous session of Congress, but was not enacted.

Introduced Mar 05, 2012
Referred to Committee Mar 05, 2012
Full Title

To amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedited approval of drugs for serious or life-threatening diseases or conditions.


No summaries available.

21 cosponsors (12R, 9D) (show)

House Energy and Commerce


The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards.
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition.
Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on:
(1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or
(2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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