A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
The failure of Congress to renew the rare pediatric disease priority review voucher (PRV) program at the end of 2024 has left biotechs reeling. A BioSpace analysis turned up 11 vouchers handed out last year—the most of any year since the program’s inception in 2014. Eighty vouchers have been issued in total over the past decade, including four of the vouchers so far this year.
To reflect the sunsetting of the program, the price for a voucher has spiked to $150 million. The most ever paid for a PRV was AbbVie’s $350 million purchase of United Therapeutics’ voucher in 2015. The cheapest was $21.2 million paid by Novartis in 2023 for a voucher from Pharming Technologies.
Gilead has spent at least $621 million in known purchases of PRVs, while Novartis has earned or bought the most with eight. Sarepta has earned the most overall with four for its various Duchenne muscular dystrophy therapies. That rare disease has benefitted the most from the rare pediatric disease program, with seven total therapeutics approved and granted vouchers.
BioSpace compiled all of the 80 known vouchers in the below chart.
About the data: BioSpace compiled the list of priority review vouchers through dozens of sources, including the FDA, Federal Register, SEC, GAO, company reports, news articles and more. Still, the list may not be comprehensive, as there are often PRV transactions that go unreported.
