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BPCA and PREA Reauthorization Act of 2012

Introduced: March 28, 2012 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 28, 2012
Referred to the House Committee on Energy and Commerce.
Mar 28, 2012
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now March 30, 2012

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1