S. 2236 (112th): Advancing Breakthrough Therapies for Patients Act of 2012

Mar 26, 2012 (112th Congress, 2011–2013)
Died (Referred to Committee) in a previous session of Congress

This bill was introduced on March 26, 2012, in a previous session of Congress, but was not enacted.

Mar 26, 2012
Michael Bennet
Junior Senator from Colorado
Read Text »
Last Updated
Mar 26, 2012
8 pages
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Full Title

A bill to provide for the expedited development and evaluation of drugs designated as breakthrough drugs.


No summaries available.

2 cosponsors (2R) (show)

Senate Health, Education, Labor, and Pensions

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Primary Source

THOMAS.gov (The Library of Congress)

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S. stands for Senate 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.

Advancing Breakthrough Therapies for Patients Act of 2012 - 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.
Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations.
Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

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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