The Priority Review Voucher Program: Incentivizing Neglected Disease Research and Promoting Biotech Investment and Development for More than a Decade
June 16, 2025
Breakout Session
Business Development and Investment
210A
This session will explore the priority review voucher (PRV) program as proposed in a 2006 paper by Ridley, Grabowski, and Moe and became law in 2007. The PRV allowed the FDA to encourage R&D in neglected disease areas. A company with a successful drug approval in a specified area is given a PRV for a different drug application. The PRV can be sold, often to a large pharma company, for $100 million or more. The FDA aims to review the PRV user’s drug submission in about six months instead of ten. The PRV thus allows faster entry to market with benefits to patient health, as well as company revenue and competitive advantage. Sales of PRVs total more than a billion dollars while boosting development of many drugs for neglected and rare diseases. Despite this, the PRV program is still poorly understood or completely unknown to many stakeholders. Join us to learn more!
Moderator
Speakers
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Chief, Business Development and Commercialization, Office of Medical Technology Transfer
U.S. Army Medical Research and Material Command
Special Advisor, NIH Office of Technology Transfer
National Institutes of Health
Senior Director, Patient Advocacy
Biotechnology Innovation Organization (BIO)
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