Innovation in Pediatric Drugs Act of 2023

HR 6664 requires the FDA to apply pediatric drug testing requirements to orphan drugs (treatments for rare diseases) that were previously exempt. It directs the FDA to issue guidance within 18 months on how these requirements will work, including when waivers for impractical studies are allowed, and increases annual funding for pediatric studies to $50 million. Drug sponsors developing orphan medications must now provide more pediatric safety data, while the FDA gains clearer enforcement rules for compliance. The bill also mandates an FDA report on compliance and a government study on the law's impact on rare disease drug development.