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Duke Faculty Propose Incentives For Developing Drugs For Neglected Diseases

Under the proposal, a drug developer with a treatment for a neglected disease would receive a 'priority review voucher' from the FDA for expedited review of a second treatment of its choice

Duke University researchers have proposed a system that would give pharmaceutical companies incentives for developing drugs for neglected diseases, like leishmaniasis and dengue fever, that primarily affect people in poor countries.

Under the proposal, a drug developer with a treatment for a neglected disease would receive a "priority review voucher" from the Food and Drug Administration (FDA) for expedited review of a second treatment of its choice. The voucher could be sold to another company or acquired as part of a buyout of its owner.

"Tropical and infectious diseases cause enormous suffering, but because the victims are in poor countries there is little or no profit for pharmaceutical manufacturers," said David Ridley, one of the authors of the proposal and an assistant professor at Duke's Fuqua School of Business. "Our plan makes it commercially viable to develop new therapies for neglected diseases."

Ridley, along with co-authors Jeffrey Moe, an executive in residence at Fuqua, and Henry Grabowski, an economics professor at Duke, laid out their proposal in a paper published in the March 9 issue of the journal Health Affairs. Their work was supported by funding from the GlaxoWellcome Foundation and Fuqua's Center for the Advancement of Social Entrepreneurship.

"Our concept has benefits for U.S. consumers, discovery-driven companies and neglected disease sufferers," Moe said. "We hope our proposal will encourage others to bring forward other novel approaches. Those of us who have benefited so greatly from the fruits of innovative research and development shouldn't accept 'market failure' as insurmountable when so many suffer globally."

Because priority review could reduce the time required to gain FDA approval of a drug by as much as one year, the researchers estimate that priority review of a blockbuster drug could bring its manufacturer more than $300 million in additional market value. By adding existing tax credits for research on conditions that are rare in the U.S., the award's total value could exceed $550 million, they said.

This would not only provide a return on investment for the company developing a drug for a neglected disease, but make that company an attractive target for acquisition by other companies desiring to quickly bring therapies to lucrative Western markets, the authors said.

The proposal would not only bring sorely needed new treatments to the developing world, the priority review system would also have benefits for U.S. patients by providing earlier access to new drugs, the researchers argue. Furthermore, because drugs with expedited FDA clearance will typically have their patents expire earlier, consumers also would have earlier access to lower-priced generics.