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First, priority review is safe.3 Priority review should not be confused with "accelerated approval" or "fast track." Priority review does not omit safety or efficacy studies or require approval within a given time frame. It sets a target of 6 rather than 10 months for FDA review.
Second, the voucher program is efficient because it can alleviate tremendous suffering at little government cost. Our analysis shows that it will provide substantial net benefits to patients and drug developers,2 while the additional cost of priority review will be covered by an extra user fee paid to the FDA.
Third, the voucher program will be effective. Kesselheim argues that "manufacturers will be unlikely to start such a program merely because of the prospect of earning a voucher some years in the future, since the voucher's value depends on the success of potential `blockbuster' drugs." Uncertainty is in the nature of the pharmaceutical business. The voucher could be worth more than $100 million, which should at least motivate firms to take products off their shelves and put them into late-stage clinical trials.
Fourth, the voucher program is of reasonable scope. Kesselheim argues that the scope is too narrow because the voucher prize is not given to manufacturers of follow-on formulations. Conversely, some argue that the scope is too broad, in that vouchers are awarded to manufacturers of treatments that are already available in countries outside the United States. We respect suggestions for improving the law's provisions, but we think the current compromise is reasonable. The current priority-review voucher program can provide new incentives for drug development at relatively low government cost, speed the review of another product that the market values, and even speed approval of the generic version of that product.
Other mechanisms are also worthwhile, and we hope that the priority-review voucher program will complement them. Selling a voucher can provide funds for private development partnerships. We also support funds for push mechanisms (e.g., funding of clinical trials) and pull mechanisms (e.g., advance market commitments).4
Jeffrey Moe, Ph.D.
Henry Grabowski, Ph.D.
David Ridley, Ph.D.
Duke University
Durham, NC 27708
david.ridley{at}duke.edu
Drs. Moe, Grabowski, and Ridley were the authors of the original priority-review proposal. That research was funded by the GlaxoWellcome Foundation and the Center for the Advancement of Social Entrepreneurship. No other potential conflict of interest relevant to this letter was reported.
References
Finally, with regard to the treatment of neglected diseases affecting millions of patients across the world, Moe et al. argue that many promising drugs that are ready for late-stage development have not been taken off manufacturers' shelves because of insufficient financial incentives. If true, this is an alarming indictment of the industry. Pharmaceutical development is largely driven by companies that derive their revenues from patent-protected market exclusivity. In addition to inadequately addressing "unprofitable" diseases, this incentive structure has been exploited by manufacturers to garner undeserved revenue at the expense of patients and payers.3
It is not a stretch to predict similar behavior after the adoption of a priority-review voucher program. The first voucher is likely to be received by Novartis for the antimalarial treatment artemether–lumefantrine (Coartem), a product that has long been available outside the United States.4 Yet there is no guarantee that Novartis's windfall of $100 million (or more) in this case will be invested in delivery of the drug to needy patients or in further research.5 The optimal way to address neglected diseases is not to create ever more convoluted incentives that are easily prone to misuse, but instead to enhance public investment in research while ensuring that the results are made available in such a way as to achieve the greatest benefit for the public health.
Aaron S. Kesselheim, M.D., J.D.
Brigham and Women's Hospital
Boston, MA 02115
References
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