GAO Critiques FDA’s Priority Review Voucher Programs

Priority review vouchers (PRVs) may have little to no effect on drug development, the Government Accountability Office (GAO) concluded in a report— although some drugmakers surveyed said otherwise.

The FDA created three PRV programs to encourage the development of drugs for certain tropical and rare pediatric diseases. The vouchers are granted after new drug approval and may be redeemed at a later date to receive priority review on a drug — shaving four months off the 10-month standard review — or they may be sold to another sponsor.

GAO found that, of the 31 PRVs awarded between FY 2009 — when the first voucher was issued — and FY 2019, more than half were purchased by other sponsors at prices ranging from $67 million to $350 million.