The US Congress created the priority review voucher program in 2007 based on a 2006 Health Affairs paper (Ridley et al. 2006). The voucher entitles the bearer to regulatory review in about six months rather than the standard ten months. The Food and Drug Administration (FDA) awards a voucher following approval of a treatment for a neglected disease, rare pediatric disease, or medical countermeasure. Two drugs receive priority review for each voucher: the drug winning a voucher for a neglected or rare pediatric disease, and the drug using a voucher for another indication.
The voucher may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease, and sell the voucher to a large company for use on a commercial disease.
The voucher program is intended to reduce two types of inefficiency. First, the voucher program motivates more treatments for neglected diseases, rare pediatric diseases, and medical countermeasures. Second, the voucher program speeds approval of potential blockbuster therapies in the US, getting US patients access to these treatments more quickly.
By moving a drug to faster review, there is the potential to slow other drugs. To provide FDA with more resources and mitigate this cost, the voucher holder must pay the FDA an additional user fee ($2,116,167 in fiscal year 2020). The FDA can include in its budget request the expectation of redeemed vouchers. For example, if the FDA consistently has 4 vouchers redeemed each year, it can consistently request an extra $10 million.
The voucher has three effects on commercial value: the competitive effect, the time-value of money effect, and the exclusivity effect (Ridley and Régnier 2016).
According to a 2020 report from the Government Accountability Office (GAO) about the priority review voucher (PRV) program, “all seven drug sponsors GAO spoke with stated that PRVs were a factor in drug development decisions—six sponsors said they were one of a number of factors, while one sponsor said they were pivotal in its development of a drug.”
The Global Health Investment Fund announced that it provided $10 million to non-profit drug developer Medicines Development of Australia to complete registration of moxidectin, a drug for river blindness. Because river blindness does not affect people in rich countries, moxidectin had been languishing on the shelf of a drug manufacturer. According to Mark Sullivan, the CEO:
“Medicines Development for Global Health’s ability to attract the finances required to complete the final stages of moxidectin’s development was a direct result of the value of the voucher. Even then, the risk/benefit debate diminished only once two commercial voucher transactions had taken place and the theoretical market value had become a confirmed value. Without this mechanism, moxidectin would have been a missed opportunity for global health” (Email correspondence with Mr. Sullivan, January 2016).
Priority review vouchers do not expire. Furthermore, the priority review voucher program for neglected diseases (enacted in 2007) does not sunset. However, the program for rare, pediatric diseases will expire in October 2020, although a drug designated as a rare pediatric treatment can still receive a voucher if the drug is approved by October 2022. Furthermore, the program can be renewed, and Congress has renewed the program several times already.
David Ridley, Henry Grabowski, and Jeff Moe proposed the voucher in a paper published in 2006. David presented the team’s draft paper at several conferences, including the June 2004 meeting of the Drug Information Association, the January 2005 meeting of the American Economic Association, and the July 2005 meeting of the International Health Economics Association. In 2006, the voucher proposal was the lead article in Health Affairs. After Health Affairs published the paper, David presented the paper at the National Press Club on March 7, 2006. After the press conference, Laura Blinkhorn (a reporter for Congressional Quarterly) told David that Senator Brownback (R-KS) would be interested. David and Jeff met with Senator Brownback and his staff (including Melanie Benning). Senator Brown (D-OH) and others joined Senator Brownback in sponsoring the bill. In a later issue of Health Affairs, Senator Brownback wrote, “After reading their proposal in Health Affairs, I met with Ridley and colleagues to discuss the idea further, and I subsequently drafted an amendment… Indeed, their idea is the heart of my Elimination of Neglected Diseases (END) amendment” (Brownback 2007).
In 2008, Bill Gates speaking at the World Economic Forum in Davos in 2008, said “But some of the highest-leverage work that government can do is to set policy and disburse funds in ways that create market incentives for business activity that improves the lives of the poor. Under a law signed by President Bush last year, any drug company that develops a new treatment for a neglected disease like malaria or TB can get priority review from the Food and Drug Administration for another product they’ve made. If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier. This priority review could be worth hundreds of millions of dollars” (transcript, video, video excerpt).
This web page is maintained by David Ridley, one of the authors of the priority review voucher program.