Two months ago, a new program got under way in the US to promote the development of drugs for so-called neglected diseases that continue to plague the poorest nations. Here is the outline: a drugmaker that seeks approval of a drug to treat one of these infectious diseases gets a voucher, which awards an expedited FDA review of a new drug application for any other med (here is the FDA draft guidance).

The idea, of course, is to give a drugmaker incentive to develop needed meds. How so? An FDA expedited review takes six months, comapred with the average review time of 12 months. For a drug in a big-selling category, the voucher could be worth $300 million, or much more. But there’s a wrinkle - vouchers can be sold, creating the potential for abuse, according to an essay in The New England Journal of Medicine by Aaron Kesselheim of Brigham and Women’s Hospital in Boston.

The vouchers “represent an inefficient and potentially dangerous way of encouraging research into tropical diseases,” he writes. “It is inefficient because the program does not directly connect the incentive with the innovation.” In his view, drugmakers are unlikely to research needed meds, because the value of voucher depends on the success of potential blockbusters in the pipeline. Small companies, however, often have limited pipelines.

“Such companies will often be unable to use their vouchers, although the law permits voucher rights to be sold to a large manufacturer. Relying on these sorts of transactions to spur innovation is speculative as well, and the deals between small and large pharmaceutical companies affecting agents of great importance to global health will lack transparency,” he writes.

Novartis, however, may have found a way to make out. As GoozNews notes, the drugmaker already sells the Coartem malaria drug, which is a combination of an artemisinin extract and lumefantrine. Both are already approved in the US, but not as a combined pill. So Novartis is seeking FDA approval and has an appearance before an agency advisory committee next month.

The upshot: Novartis gets a voucher that can be sold for a lucrative price; the other drugmaker may get a windfall, depending upon the type of med for which the voucher is used; and consumers will not receive anything, since Coartem is already marketed. UPDATE: “A Novarits spokeswoman writes this: Novartis’ decision to file a new drug application in the US for Coartem was based on unmet need in the US…

“Currently, US citizens and military personnel travelling to malaria-endemic countries do not have access to an FDA approved artemisinin-based combination treatment (ACT), the standard-of-care treatment for malaria.

“Coartem is the only fixed-dose ACT that has already been approved by health authorities worldwide and is available to patients in more than 60 countries, including 16 European nations. If approved by the FDA, Coartem would be the first ACT approved for use in the US, giving US patients the same standard of treatment available to patients around the world.

“Our decision to pursue FDA approval was made prior to the enactment of PRV, and PRV played no part in our decision. We made the decision to file an NDA based on unmet patient need in the US and with encouragement from FDA. While the PRV incentive did not influence our decision to pursue FDA approval, we do see the new program as a benefit for patients with neglected diseases, and hope that it will incentivize other research-based organizations to invest in rare or neglected diseases and to join Novartis in the research, development, and delivery of innovative treatments for malaria and other diseases.”