A study of whether the vouchers work is due, with a report in five years
What the document says“The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases”
Subsection (c) of section 6604 requires the Comptroller General to study how effective the vouchers have been. The study must cover the indications for each drug that won a voucher and was approved, whether an unmet need was met, the size of the company that won a voucher and of the one that used it, the voucher's value if transferred, which drugs vouchers were used for, the time between award and use, whether companies were motivated by the vouchers, whether the vouchers sped patient access, their effect on the agency's workload and priorities, and other incentives in federal law. The report is due to two committees within five years of enactment.
What the document actually says“The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases”
A watchdog office must study whether these vouchers work. The question is whether they lead to drugs for rare diseases in children.
A voucher can be sold to another company. So it has a price. The study looks at that and at whether new drugs actually came of it.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.