Priority Review Vouchers and FDA: Agency Complains of Increased Work
[Posted on: Thursday, 03 March, 2016]

A recent GAO report on the public support for the Priority Review Voucher (PRV) program presents a mixed picture where the industry loves the program and wants it to be maintained while the FDA has an exactly opposite opinion. PRVs have been around for about 7 years since the first PRV program was implemented in 2007 with great fanfare. A PRV guarantees 6 month review for an application that otherwise will be reviewed under the standard timeline of 10 months. The program was originally proposed to incentivize development of treatments for tropical diseases, an area not touched by the pharma companies in developed countries for lack of patients in the US. Tropical disease vouchers were expected to encourage companies to develop and seek approval for products intended to treat diseases for which there would likely be limited profits, if any. The value of the PRV is in reducing time to market for a conventional product translating into higher profits. The real incentive was that the company who won the PRV could sell it to another company. And indeed one of the tropical PRV was sold for $125 million. Three companies won the PRV for tropical diseases. The PRV program was expanded by President Obama in 2012 to add rare pediatric diseases presumably based on the success of the tropical disease PRV program. The rare pediatric PRV (RP-PRV) was originally intended for a three year period only and is expected to end on 31 Oct 2016. The RP-PRV program had additional changes that greatly extended the financial benefit to the winner of these PRVs. Unlike the tropical disease PRV, the RP-PRV could be sold multiple times making sale and resale possible, and the notice period for using an RP-PRV was reduced to 90 days from 1 year. The RP-PRV could be revoked if the pediatric drug approved under this program was not marketed within a year of approval, and the company granted RP-PRV must report to the FDA the use of their drug within 5 years of approval. Six RP-PRVs have been granted since its inception 3 years ago and one of these was sold for a whopping $350 million. The benefit to the industry is clear. The GAO review was aimed at evaluating the RP-PRV for the public. For its review, GAO interviewed several pharma companies, academic professionals and FDA officials. As would be expected, the industry representatives believe the RP-PRVs are highly beneficial and should be extended. The academic professionals had mixed feelings with some supporting it while others indicated limited or no benefit. The FDA officials on the other hand opposed the RP-PRV program citing no apparent benefit and several challenges to FDA’s other public health obligations due to the RP-PRV. FDA believes that PRVs strain its resources and increase workload on its reviewers due to the tight time-lines guaranteed under the RP-PRV. It is easy to take sides in this debate based on one’s affiliations but some points need to be considered. First, to use a PRV, a company has to pay additional fees to the FDA of $2.4 million in addition to the PDUFA user fee. Hence it does provide extra financial resources to the Agency to hire additional reviewers. Agreed that it take time to hire and train additional reviewers but should the program be continued and expand, it should give FDA time to update its resources to meet the extra demand. The Agency has done similar updates to other programs such as the biosimilar program and the generic drug reviews. Second, FDA only made comments for the RP-PRV program, presumably because of the narrow nature of the GAO review. So, the tropical disease PRV is here to stay making it necessary for FDA to update its resources anyway. Third, it has been only three years since the RP-PRVs were launched and 7 years since the tropical disease PRVs. This time is too short to evaluate the utility or futility of the PRVs. Even the GAO report concluded that three years is insufficient time to evaluate the program. All together, the case to close the PRV program is weak at best. With the strong industry support, it is safe to say that the PRV program is here to stay. Even if the RP-PRV program is not extended the tropical PRVs will still have a similar program available to the industry.