Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health

The 21st Century Cures Act expanded the priority review voucher (PRV) program to include medical countermeasures against chemical, biological, radiological, and nuclear threats, despite limited evidence that the program has achieved its stated goal of incentivizing new drug development. The authors analyze the implications of this expansion, noting that vouchers have been sold for up to $350 million and raising concerns that the program’s broadening may further dilute its intended incentive effect while generating substantial financial rewards for manufacturers without requiring genuinely novel research.