Innovation in Pediatric Drugs Act of 2023

This bill encourages innovation in pediatric drug development by removing the exemption for orphan drugs from pediatric study requirements, reauthorizing a pediatric studies program with increased funding, ensuring accountability for completing pediatric studies, and requiring reports on enforcement.

Sec. 2, Pediatric studies of orphan drugs: This section removes the exemption that previously allowed orphan drugs (drugs for rare diseases) to be excluded from pediatric research requirements. The change applies to certain drug applications submitted 18 months after the bill becomes law. The Secretary of Health and Human Services must issue guidance on how the pediatric study requirements will apply to orphan drugs, including rules for waivers, study plans, and use of real-world evidence. A public meeting must be held to inform the guidance. The Government Accountability Office must study the impact of this change on rare disease drug development and pediatric drug labeling.

Sec. 3, Reauthorizing the program for pediatric studies of drugs: This section increases the annual funding for the pediatric studies program from $25 million to $50 million for each fiscal year from 2023 through 2027.

Sec. 4, Ensuring completion of pediatric study requirements: This section removes a previous exception that prevented the FDA from taking enforcement actions (like penalties) against drug sponsors who fail to complete required pediatric studies. It also adds pediatric study requirements to the list of violations that can lead to civil penalties. The FDA cannot enforce this change for failures that occurred before 180 days after the bill becomes law.

Sec. 5, FDA report on PREA enforcement: This section expands the FDA's annual report on pediatric studies to include an assessment of deferrals and deferral extensions, and a listing of any penalties, settlements, or payments made for failing to comply with pediatric study requirements, including the drug name, sponsor, and amount.