What is the official ID of this bill?
The official print number for this legislation is S 3302.
Expanded Pediatric Cancer Drug Testing and Rare Disease Incentive Extension.
This law expands the requirement for testing new cancer drugs on children if the drug's molecular target is relevant to pediatric cancers. Furthermore, it extends the incentive program (priority review vouchers) for pharmaceutical companies developing treatments for rare pediatric diseases until 2030. The goal is to accelerate access to safe and effective therapies for the youngest patients suffering from serious conditions.
Key points
Companies introducing new adult cancer drugs must now study their use in children, including in combination with existing standard-of-care treatments, if the molecular target is relevant to pediatric cancers.
The program rewarding companies for developing rare pediatric disease drugs (via expedited review of other drugs) is extended until September 2030.
The changes aim to increase the amount of clinical data available regarding the dosing and safety of cancer drugs for different pediatric age groups.
Status:
Introduced
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