Mikaela Naylon Give Kids a Chance Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill, the Mikaela Naylon Give Kids a Chance Act, aims to expand the Food and Drug Administration’s (FDA) authority regarding pediatric cancer research and drug approvals. It allows for combining approved drugs with active ingredients in pediatric studies, strengthens enforcement actions against drug sponsors who fail to meet pediatric study requirements, reauthorizes funding for pediatric research, and clarifies the interpretation of orphan drug exclusivity periods. The bill also includes provisions to improve collaboration between the FDA and Abraham Accords countries.
Key provisions
- Permits the FDA to take enforcement action against drug sponsors who don’t meet pediatric study requirements.
- Allows for combining approved drugs with active ingredients in pediatric cancer investigations under certain conditions.
- Renews the FDA’s authority to award priority review vouchers for rare pediatric disease treatments.
- Clarifies the interpretation of orphan drug exclusivity periods.
- Establishes an Abraham Accords Office within the FDA to facilitate regulatory collaboration with Abraham Accords countries.
- Requires the FDA to provide technical assistance to regulatory partners in Abraham Accords countries.
- Extends funding for the National Institutes of Health to support priority pediatric research.
- Modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved.
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