US Congress House Bill 4274 (Prior Session Legislation)

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March 30 2012 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

BPCA and PREA Reauthorization Act of 2012

Rep Rogers, Mike J.

Rep Eshoo, Anna G.

Rep Markey, Edward J.

Date	Chamber	Action
2012-03-30	House	Referred to the Subcommittee on Health.
2012-03-28	House	Referred to the House Committee on Energy and Commerce.

HB5651 (Related) 2012-06-04 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.

Type	Source
Summary	http://thomas.loc.gov/cgi-bin/bdquery/z?d112:HN04274:@@@L&summ2=m&
Text	http://gpo.gov/fdsys/pkg/BILLS-112hr4274ih/pdf/BILLS-112hr4274ih.pdf