Vouchers For FDA Priority Reviews

David Ridley and colleagues (Mar/Apr 06) deserve praise forseeking market-based mechanisms to encourage the developmentof medicines and vaccines for diseases primarily affecting thepoorest nations, but their prescription—a transferablevoucher for priority review by the U.S. Food and Drug Administration(FDA)—is built on faulty assumptions.

They come to the value of an FDA priority review on the basisof an estimate that a standard review takes 18.4 months anda priority review takes 6.4 months. According to the FDA, infiscal year 2003 the actual times for standard reviews were13.8 months and 6.4 months, respectively. More important, underthe Prescription Drug User Fee Act (PDUFA), the FDA has committedto delivering action on 90 percent of applications for standardreviews within ten months and for priority reviews within sixmonths. A better estimate of time saved, then, is four to sevenmonths, which would change the paper’s estimate of thevalue of the proposed incentive.

In addition, the proposal depends on the FDA’s doing priorityreviews for drugs and vaccines that it otherwise would not deemas meriting the required resources. Although the authors proposerequiring drug companies to pay an additional user fee for this,it is not obvious that the fees would be enough to ensure thatthe FDA would have the expert human resources to do so withouttaking away from reviewing medicines and vaccines that it believesneed priority review.

Market mechanisms are the key to creating incentives for drugcompanies to increase research and development (R&D) commitmentsto meet the needs of the developing world. Strong advance purchasecommitment (APC) proposals, which are advancing rapidly, arethe most direct way to create these incentives.

Ian D. Spatz

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Vouchers For FDA Priority Reviews