FDA Pediatric Incentives, Powers Would Become Permanent Under Draft Bill

In the absence of sunset provisions that necessitate periodic reauthorization of the pediatric laws, GAO would report to Congress on a five-year cycle about the accomplishments of the drug programs for children and make recommendations for amendments.

Draft legislation being circulated by House Energy and Commerce Committee Republicans would eliminate sunset provisions in the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

This would end congressional reassessment of pediatric exclusivity that occurs every five years when the two laws are reviewed as part of the

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