BPCA in its entirety is mandated to:

  • Identify drugs in need of further study
  • Prioritize needs in pediatric therapeutics
  • Sponsor clinical studies of prioritized drugs

​To accomplish these activities, NICHD collaborates with the U.S. Food and Drug Administration, other NIH Institutes, pediatric experts, and the public to help maximize its research. 

As important as drug development is in children, many issues discourage the testing of drugs in children. These include: the lack of incentives for pharmaceutical companies; ethical issues involving parental permission and the child's assent; the unforeseeable nature of some clinical responses in immature individuals, leading to the possibility of unanticipated adverse reactions; the threat of effects on growth, development, or health long after the drug's administration; the difficulty in predicting dose-response or concentration-response relationships based on data extrapolated from adults; and the lack of a suitable infrastructure for the conduct of pediatric pharmacology research. As a result, the majority of drugs used in children today are used off-label, without adequate understanding of appropriate dose, safety, or efficacy. The goal of BPCA legislation is to improve the drug development pipeline of medications available to children. 

At the top is a blue box which says 'BPCA legislation'. Below are two gray boxes. The one on the left says 'FDA' (on patent)'; the right box says 'NIH (off-patent)'. Below the FDA box are two yellow boxes. On the left it says 'Pharmaceutical Companies' Drug Studies'. On the right it says 'Pediatrics Division Oversight'. Below the NIH box is a yellow box on which it says 'Prioritization Clinical Trials Training'.


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