HR 2887 · 107th Congress · Health
Best Pharmaceuticals for Children Act
Bill Progress
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Introduced✓
Committee✓
House Vote4
Senate5
EnactedLatest: Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.(2001-11-16)
Recorded Votes
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Plain Language Summary
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Best Pharmaceuticals for Children Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, through the National Institutes of Health, to develop an annual list of approved drugs for which: (1) there is an approved or pending new drug application or no patent or market exclusivity protection; and (2) additional pediatric safety and effectiveness studies are needed. Directs the Secretary to award contracts to entities with appropriate experience for pediatric clinical trials of such drugs. Establishes a Food and Drug Administration (FDA) contract process for related labeling changes. Amends the Federal Food, Drug, and Cosmetic Act to: (1) eliminate the user fee waiver for pediatric supplements to a human drug application; (2) provide priority status for pediatric supplements; (3) include neonates within the definition of pediatric studies; (4) provide for dissemination of pediatric supplement information; and (5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs. Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food an…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeH.R. 2887, Best Pharmaceuticals for Children Act
Nov 6, 2001<p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on October 11, 2001</p>
Full CBO report ↗H.R. 2887, Best Pharmaceuticals for Children Act
Nov 6, 2001Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on October 11, 2001
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (20)
14 Democrats6 Republicans