Accelerating Pediatric Cancer Drug Research: New FDA Rules and Incentives Extended.
This Act aims to accelerate the investigation of new molecularly targeted cancer drugs for children. It mandates pharmaceutical companies to study their adult cancer drugs for pediatric use if the molecular target is relevant to childhood cancers. Furthermore, it extends the Priority Review Voucher program until 2029, which incentivizes companies to develop treatments for rare pediatric diseases, potentially increasing the availability of life-saving therapies for young patients.
Key points
Mandatory Pediatric Investigations: Companies developing new adult cancer drugs must conduct molecularly targeted pediatric cancer investigations if the drug's target is relevant to childhood cancers.
Faster Drug Access for Children: The changes are designed to speed up the testing and approval of oncology drugs for children, potentially leading to better treatment outcomes.
Extension of Financial Incentives: The Priority Review Voucher program for rare pediatric disease drugs is extended until September 2029, encouraging industry investment in these critical therapies.
Accountability and Review: The government will conduct studies to assess the effectiveness of these new rules and incentives in actually developing drugs for pediatric cancer and rare diseases.
Introduced
Additional Information
Print number: 119_S_932
Sponsor: Sen. Mullin, Markwayne [R-OK]
Process start date: 2025-03-11