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HR 4332 112th Congress House Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Executive agency funding and structure Food and Drug Administration (FDA) Intellectual property Prescription drugs

Generic Drug Application Review Fairness Act of 2012

Introduced: March 29, 2012 Introduced by: Pallone, Frank Democratic · New Jersey See on congress.gov
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 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
 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).

What's happening now March 30, 2012

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Democratic 1 Republican 1