United States 112th Congress Status: Died 1 D cosponsors

HR 4332 — Generic Drug Application Review Fairness Act of 2012

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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).

Bill Text

We don't have the full text on file for this bill yet.

Read HR 4332 on the official United States source →

Action History

  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 4332 do?
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).
Who sponsors HR 4332?
HR 4332 is sponsored by Frank Pallone (D).
What is the current status of HR 4332?
This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 4332?
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Last checked for changes about 18 hours ago · updated continuously

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