This bill amends federal drug approval requirements to strengthen pediatric drug development and research. It modifies how the FDA enforces requirements for drug manufacturers to study their medications in children, including giving companies a 45-day period to respond to noncompliance notices before penalties are issued. The legislation also requires the FDA to publish lists of diseases where pediatric studies are automatically waived due to being impractical or unnecessary, providing more certainty for drug developers. Additionally, the bill authorizes the National Institutes of Health to use up to one percent of pediatric research funding at each institute for pediatric drug studies in fiscal years 2025 through 2027, and it requires the FDA to issue guidance on how pediatric study requirements should apply to rare disease drugs. The bill directs the Government Accountability Office to study the law's impact on rare disease drug development within four years of implementation.
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