Best Pharmaceuticals for Children Act

Summary

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 exclusivity for which pediatric studies are needed. Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities. Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/benefits assessments in terms of research versus therapeutic treatment.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 4 October 2001

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• Introduced in House (PDF)

  Introduced in House · EN · 4 October 2001

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• Introduced in House

  summary · EN · 4 October 2001

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