The COVID-19 global pandemic reminds us of the importance of investing in preventing and treating infectious diseases. Until the COVID-19 pandemic, the largest US government-sponsored reward for infectious disease drug and vaccine development was the Tropical Disease Priority Review Voucher program. Under the voucher program, the Food and Drug Administration awards a priority review voucher to the sponsor of a new drug or vaccine for tropical infectious diseases. The voucher can be sold for the faster review of a different drug.
HSM Faculty Director David Ridley, with two other Duke faculty, proposed the priority review voucher program in a 2006 paper that became law in 2007. More than a decade later, Professor Ridley and coauthors review the first seven voucher recipients for drugs and vaccines for neglected diseases.
Voucher program successes include (1) helping a non-profit drug developer restart development of a river blindness drug, (2) providing a commercial rationale for a large drug maker to continue tuberculosis development while forgoing lucrative opportunities, and (3) supporting patient access to a Chagas drug.
However, the voucher program needs complementary incentives. Voucher prices have been about $100 million for the past two years, but this is down from a high of more than $300 million. A voucher worth $100 million helps motivate late-stage drug development, but is insufficient for risky early-stage development.
Furthermore, just because a drug is developed, does not guarantee that it reaches patients in lower-income countries. Fortunately, there is a commitment to patient access from five of the first seven voucher recipients for drugs and vaccines for neglected diseases.
Professor Ridley’s priority review voucher web page: https://priorityreviewvoucher.org/
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