H.R. 4274 (112th): BPCA and PREA Reauthorization Act of 2012

Introduced:
Mar 28, 2012 (112th Congress, 2011–2013)
Sponsor:
Rep. Mike Rogers [R-MI8]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on March 28, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Mar 28, 2012
Referred to Committee Mar 28, 2012
Cosponsors
2 cosponsors (2D) (show)
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003.

Summary

No summaries available.

Text

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Last updated Mar 28, 2012.
22 pages

Primary Source

View on THOMAS (The Library of Congress)

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

3/28/2012--Introduced.
BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA). Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity.
Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change.
Requires a product sponsor to submit an Initial Pediatric Plan as part of the drug application process and sets forth the process for such submission.
Authorizes the Secretary of Health and Human Services (HHS) to:
(1) grant a deferral extension, and sets forth the conditions for such deferral; and
(2) issue a non-compliance letter to a product sponsor failing to meet post-marketing requirements, and requires the product sponsor to respond in writing.
Authorizes the Pediatric Review Committee to review deferral extensions.
Requires the Office of Pediatric Therapeutics to include a neonatologist and pediatric epidemiologist.
Reauthorizes the Pediatric Advisory Committee and the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

Slip Laws

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United States Code

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