Generic Drug Application Review Fairness Act of 2012

Summary

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).

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Timeline

1. 29 March 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 29 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 29 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 30 March 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 29 March 2012 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 29 March 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 29 March 2012

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 29 March 2012

  Open at official source

Sponsors

• Frank Pallone · D · Sponsor
• Brett Guthrie · R · Sponsor
• Rep. Matheson, Jim [D-UT-4] · D · Cosponsor
• Michael Burgess · R · Cosponsor
• Rep. Dingell, John D. [D-MI-16] · D · Cosponsor
• Diana DeGette · D · Cosponsor
• Rep. Dold, Robert J. [R-IL-10] · R · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Food and Drug Administration Reform Act of 2012