H.R.4332 - Generic Drug Application Review Fairness Act of 2012112th Congress (2011-2012)
|Sponsor:||Rep. Pallone, Frank, Jr. [D-NJ-6] (Introduced 03/29/2012)|
|Committees:||House - Energy and Commerce|
|Latest Action:||04/30/2012 Referred to the Subcommittee on Health. (All Actions)|
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Summary: H.R.4332 — 112th Congress (2011-2012)All Bill Information (Except Text)
Introduced in House (03/29/2012)
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).