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3mo ago

FDA Launches National Priority Voucher Program to Slash Drug Review Times

The initiative is being rolled out with broad commissioner discretion over voucher awards, raising questions about oversight of its fast-track approvals.

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WASHINGTON, DC - MAY 22: U.S. Food and Drug Administration (FDA) Commissioner Martin Makary waits for the start of a Senate Appropriations Committee hearing on Capitol Hill on May 22, 2025 in Washington, DC. Members of the Senate Appropriations subcommittee on "Agriculture, Rural Development, Food and Drug Administration, and Related Agencies" held the hearing to speak to Makary about U.S. President Donald Trump's Fiscal Year 2026 Budget request for the FDA. (Photo by Anna Moneymaker/Getty Images)

Overview

  • The FDA commissioner’s new voucher program allows qualifying drug companies to have their applications reviewed in one to two months instead of the standard ten to twelve months.
  • Eligible companies must demonstrate support for U.S. priorities such as expanding domestic drug manufacturing, improving affordability, and addressing urgent public health needs.
  • The agency plans to deploy artificial intelligence tools and increase reviewer accessibility to accelerate document review while claiming no compromise to scientific rigor.
  • By offering one-month turnaround reviews, the FDA expects to create incentives worth more than $100 million in market value for companies that meet its criteria.
  • Critics warn that granting the commissioner broad discretion over voucher awards could invite political influence and weaken safeguards against premature drug approvals.