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HR 4332 112th Congress House

Generic Drug Application Review Fairness Act of 2012

Official 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 tenta… Show full official titleShow less

Official 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.

Introduced: March 29, 2012 Introduced by: Pallone, Frank Democratic · New Jersey See on congress.gov
Health Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationExecutive agency funding and structure
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Food and Drug Administration (FDA)Intellectual propertyPrescription drugs
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 30, 2012
Referred to the Subcommittee on Health.
Mar 29, 2012
Referred to the House Committee on Energy and Commerce.
Mar 29, 2012
Introduced in House
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 Latest action March 30, 2012

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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).

 Related & companion bills 1
  • HR 5651 Related bill Food and Drug Administration Reform Act of 2012
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 1 Republican 1
D
DeGette, Diana
Colorado · May 9, 2012
MATHESON, JIM
· Apr 18, 2012
 R
Guthrie, Brett
Kentucky · Mar 29, 2012
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4332: Generic Drug Application Review Fairness Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-HR-4332/
MLA
"H.R. 4332: Generic Drug Application Review Fairness Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-4332/.
Bluebook (legal)
H.R. 4332, 112th Cong. (2026), https://openamerica.io/bill/112-HR-4332/.
Markdown link
[H.R. 4332: Generic Drug Application Review Fairness Act of 2012](https://openamerica.io/bill/112-HR-4332/)
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