H.R. 4332 (112th): Generic Drug Application Review Fairness Act of 2012

Introduced:
Mar 29, 2012 (112th Congress, 2011–2013)
Status:
Died (Referred to Committee)
Sponsor
Frank Pallone Jr.
Representative for New Jersey's 6th congressional district
Party
Democrat
Text
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Last Updated
Mar 29, 2012
Length
7 pages
Related Bills
H.R. 5651 (Related)
Food and Drug Administration Reform Act of 2012

Passed House
Last Action: May 30, 2012

 
Status

This bill was introduced on March 29, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Mar 29, 2012
Referred to Committee Mar 29, 2012
 
Full Title

To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to extend the period for a first applicant, with respect to a generic drug, to obtain tentative approval without forfeiting the 180-day exclusivity period, and for other purposes.

Summary

No summaries available.

Cosponsors
6 cosponsors (3D, 3R) (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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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.


3/29/2012--Introduced.
Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements.
Limits extension coverage to applications filed within 30 months preceding the enactment of this Act.
Reduces such extended period by six months per year over a five-year period, beginning on October 1, 2013.
Directs the Secretary of Health and Human Services (HHS) to maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA).

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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