The Priority Review Voucher Program was created as an incentive for pharmaceutical companies to develop drugs for neglected diseases. In order to receive a priority review voucher (PRV), a product application must meet the criteria of the Neglected Tropical Disease or Rare Pediatric Disease PRV Programs. Neglected tropical diseases are infectious diseases that affect more than a billion people in 149 countries, most of which are in the developing world. A rare pediatric disease is a disease that affects fewer than 200,000 individuals in the United States, of which greater than 50% of the affected population is 18 or under.
Vouchers are awarded to companies by the FDA upon approval of a drug that meets the criteria of either PRV program. These vouchers allow the redeeming sponsor to have any application receive priority review, and can be transferred or sold to another company. This time advantage and the ability to gain market access faster than competitors can help a company establish brand recognition, set its preferred price and gain a valuable foothold in the market.
With changing regulations, uncertainty regarding the program’s future, a lack of expertise in the purchasing and selling of PRVs, and the continued growth of the rare disease market, there is a competitive advantage to having and utilizing a PRV to its maximum potential.
The mission of the Priority Review Voucher Summit is to give attendees the strategies and insight they need to ensure the successful development of a product that meets the criteria of either PRV program, accurately assess the value of PRVs, and understand the overall challenges and efficacy of the incentive program.