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Opinion Piece Explores FDA’s Priority Review Voucher Program For NTD Medicines

Financial Times: Getting medicines to the people who need them
Jeffrey Moe, professor of the Practice of Global Health at Duke University, and Kamran Rafiq, founder and communications director for the International Society for Neglected Tropical Diseases

“A decade ago, the U.S. Food and Drug Administration introduced a ‘priority review voucher’ (PRV) program to encourage the discovery of medicines for neglected tropical diseases (NTDs) affecting the world’s 1.5 billion poorest people. The scheme was an important step in that it provided an incentive for pharmaceutical companies to conduct research into NTD medicines they might otherwise not have undertaken. But it has been criticized because there is no incentive for the companies that develop new drugs to make them available to the people who need them. … Organizations such as the [Drugs for Neglected Diseases Initiative (DNDi)] and [Médecins Sans Frontières (MSF)] have criticized previous PRV awardees for pocketing the proceeds of voucher sales but not doing enough to get their drugs to patients, such as by pricing them appropriately or registering them in the countries where they are most needed. Now, however, the DNDi must practice what it preached, as it has become the most recent voucher winner for benznidazole, a drug used to treat Chagas disease, which has an estimated 8 million sufferers in poor countries. … [P]ublic commitment to increased access for poor patients through direct linkage to the voucher value demonstrates a novel approach: a voluntary access plan that does not require any action by the FDA. … Critics such as MSF say regulatory reform is essential. We disagree: we prefer the voluntary approach because the FDA does not have the skills to evaluate or monitor an access plan. … The DNDi, with its own voucher, can show the NTD community how to close the access gap in the PRV program without waiting for the U.S. Congress to make reforms that the FDA has neither the capacity nor the expertise to deliver” (2/15).