Drugmakers, patient advocates and public health experts have urged the FDA to pause or significantly revise its priority voucher program during the agency’s first public hearing on the initiative June 4.
Critics cited concerns about transparency, political influence and the agency’s review process. Peter Lurie, MD, president and executive director of the Center for Science in the Public Interest, called on the FDA to wind down the pilot, while Doctors for America said the program raises questions about whether regulatory decisions will remain fair and independent.
Several speakers questioned the program’s voucher-selection process and governance structure, arguing they could undermine public trust in the FDA. Dr. Lurie said 22 drugs have received vouchers through the program and noted that 10 are marketed by companies that have reached drug-pricing agreements with the White House. Other critics urged the agency to formalize the initiative through traditional rulemaking procedures.
Patient advocacy groups also pressed the agency to reconsider how vouchers are awarded. Representatives for porphyria and Huntington’s disease patients called for greater patient input and urged the FDA to prioritize therapies for conditions with significant, unmet medical needs.
However, drugmakers that have received vouchers defended the program. Both Johnson & Johnson and Merck said the initiative has enabled earlier engagement with FDA reviewers and accelerated reviews of high-priority therapies. Partner Therapeutics said the program reduced FDA review time for its cancer drug, Bizengri, from 10 months to six weeks.
The FDA is accepting public comments on the program through June 29. Agency officials said the feedback will help inform decisions about the pilot’s future.
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