HR 3047 · 107th Congress · Health
Best Pharmaceuticals for Children Act
Bill Progress
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Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2001-10-15)
Plain Language Summary
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Best Pharmaceuticals for Children Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish a pediatric drug studies program. Directs the Secretary to establish and maintain a list of drugs for which: (1) there is an approved market application and no patent or market exclusivity protection; and (2) additional pediatric safety and effectiveness studies are needed. Authorizes the Secretary to require holders or sponsors of certain drugs to conduct such studies on a contract payment basis. Requires the Secretary to give preference to the holders or sponsors of drugs for which the studies are requested rather than required when awarding test contracts. Sets forth procedures for making labeling changes for already marketed drugs, if so indicated by such studies. Eliminates the user fee waiver for pediatric supplements to a human drug application. Sets forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs. Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to support research on drugs lacking excl…
Summarized by Claude AI · Non-partisan · For informational purposes only