H.R. 6502 (112th): Life-Threatening Diseases Compassion through Combination Therapy Act of 2012

Introduced:
Sep 21, 2012 (112th Congress, 2011–2013)
Status:
Died (Referred to Committee)
Sponsor
Brian Bilbray
Representative for California's 50th congressional district
Party
Republican
Text
Read Text »
Last Updated
Sep 21, 2012
Length
13 pages
 
Status

This bill was introduced on September 21, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Sep 21, 2012
Referred to Committee Sep 21, 2012
 
Full Title

To amend title V of the Federal Food, Drug, and Cosmetic Act to provide for extensions of marketing exclusivity periods for drugs in certain combinations of such drugs, and for other purposes.

Summary

No summaries available.

Cosponsors
2 cosponsors (2D) (show)
Committees

House Energy and Commerce

Health

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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Citation

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Notes

H.R. stands for House of Representatives bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

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


9/21/2012--Introduced.
Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination:
(1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and
(2) includes at least two drugs that are not approved.
Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations.
Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug.
Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product.
Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations.
Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations.
Directs the Secretary to study the impact of the extension of market exclusivity under this Act.

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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