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FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

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CRS Report, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, May 1, 2007.

  • “The Best Pharmaceuticals for Children Act (BPCA, P.L. 107-109) and the Pediatric Research Equity Act (PREA, P.L. 108-155) allow the Food and Drug Administration (FDA) to offer financial and regulatory incentives to manufacturers for testing their products for pediatric use. Unless Congress acts, both programs will end on October 1, 2007. FDA has approved for adult use many products never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults would hold for younger patients. However, this off-label prescribing results in children receiving ineffective drugs or too much or too little of a potentially useful drug. Some side effects are unique to children, or children of specific ages, including effects on growth and development.”
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