HR.4274 BPCA and PREA Reauthorization Act of 2012
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.
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Summary:
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.
Actions:
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
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