H.R. 5334 (112th): To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

May 07, 2012 (112th Congress, 2011–2013)
Died (Referred to Committee)
Brian Bilbray
Representative for California's 50th congressional district
Read Text »
Last Updated
May 07, 2012
8 pages
Related Bills
S. 3187 (Related)
Food and Drug Administration Safety and Innovation Act

Signed by the President
Jul 09, 2012

H.R. 5651 (Related)
Food and Drug Administration Reform Act of 2012

Passed House
Last Action: May 30, 2012


This bill was introduced on May 7, 2012, in a previous session of Congress, but was not enacted.

Introduced May 07, 2012
Referred to Committee May 07, 2012

No summaries available.

1 cosponsors (1D) (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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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.

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 drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval.
Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.
Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations.
Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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