On April 8, 2009, the FDA announced it had awarded Novartis a one-time priority review voucher (PRV) to use towards a future new drug application, for Coartem, a malaria drug. While the PRV was designed as an incentive to develop new drugs, Coartem was developed and put on the market outside the United States years before the PRV legislation was proposed. The fact that this first PRV case is an abuse is not a good thing, as noted early by Merrill Goozner. The original proposal for the PRV was presented in a Health Affairs article by David B. Ridley, Henry G. Grabowski, and Jeffrey L. Moe. Many of the shortcomings of the PRV have been described by Aaron S. Kesselheim in an article in the New England Journal of Medicine.
Writing about the FDA decision yesterday, Merrill Goozner said:
Exactly what new drug for the developing world has been created through this allocation of scarce FDA resources to Novartis?