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HR 4274 112th Congress House

BPCA and PREA Reauthorization Act of 2012

Official 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 Pha… Show full official titleShow less

Official 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.

Introduced: March 28, 2012 See on congress.gov
Health Administrative law and regulatory proceduresAdvisory bodiesCancerChild health
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Congressional oversightConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyMedical researchPrescription drugs
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 Latest action March 30, 2012

Referred to the Subcommittee on Health.

 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.

 Related & companion bills 1
  • HR 5651 Related bill Food and Drug Administration Reform Act of 2012
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1
D
Markey, Edward J.
Massachusetts · Mar 28, 2012
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4274: BPCA and PREA Reauthorization Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-HR-4274/
MLA
"H.R. 4274: BPCA and PREA Reauthorization Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-4274/.
Bluebook (legal)
H.R. 4274, 112th Cong. (2026), https://openamerica.io/bill/112-HR-4274/.
Markdown link
[H.R. 4274: BPCA and PREA Reauthorization Act of 2012](https://openamerica.io/bill/112-HR-4274/)
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