A controversial initiative to slash drug review times at the US Food and Drug Administration (FDA) is causing significant internal turmoil and raising profound legal and ethical questions. The programme, which promises approval in as little as one month for medicines deemed to support "U.S. national interests," is stoking fears that it undermines long-established scientific standards for vetting new treatments.
Internal Confusion and Legal Quandaries
According to seven current and former staffers who spoke anonymously to The Associated Press, Commissioner Marty Makary's National Priority Voucher programme is generating fresh anxiety within an agency already rocked by layoffs, buyouts, and leadership upheavals. A core unresolved issue is which officials possess the legal authority to grant final approval for drugs cleared under this new pathway.
Traditionally, approval decisions rest with FDA review scientists and their direct supervisors, insulating the process from political appointees. However, under this scheme, a committee of senior leaders led by Dr. Vinay Prasad, the FDA’s top medical officer, holds the vote, with staff reviewers excluded. "It is a complete reversal from the normal review process," said Dr. Aaron Kesselheim of Harvard Medical School.
The programme's legal footing is shaky, as it hasn't been codified in federal regulations, unlike the FDA's other half-dozen expedited review pathways. This ambiguity led the FDA’s then-drugs director, Dr. George Tidmarsh, to refuse to sign off on approvals. After his resignation in November 2025, principal deputy commissioner Sara Brenner also declined the role after examining the legal implications. The responsibility now reportedly falls to Dr. Mallika Mundkur, who works under Dr. Prasad.
Political Pressure and Procedural Shortcuts
The initiative has proven popular at the White House, where announcements of drug price cuts by pharmaceutical companies have been paired with the awarding of FDA vouchers. For example, when Eli Lilly and Novo Nordisk agreed to reduce prices on obesity drugs, FDA staff had to scramble to vet vouchers for both firms in time for a news conference with President Donald Trump.
This linkage has sparked widespread concern that the agency's historically objective review process is now vulnerable to political interference. "It’s extraordinary to have such an opaque application process, one that is obviously susceptible to politicisation," remarked Paul Kim, a former FDA attorney.
Internally, the pressure to meet aggressive deadlines has led to directives to skip standard regulatory steps. In the review of Eli Lilly's anti-obesity pill, company executives initially demanded approval within two months, excluding the standard 60-day pre-filing period. Staffers were eventually pressured to accept a two-week turnaround. During an internal meeting, when reviewers raised concerns about missing data, a senior official advised, "If the science is sound then you can overlook the regulations."
An Expanding Programme in a Strained Agency
Initially framed as a pilot for no more than five drugs, the programme has ballooned to 18 awarded vouchers, with more under consideration. This expansion places extra strain on an agency already facing a staff exodus, with 20% of the drug centre's personnel having left over the past year through retirements, buyouts, or resignations.
While early vouchers were reportedly recommended by career staff, selections are increasingly led by Dr. Prasad or other senior officials, sometimes without the knowledge of the FDA review teams. Furthermore, Commissioner Makary's practice of not using a government email account for business, breaking with precedent, has limited internal access and transparency.
The programme's future remains uncertain. Dan Troy, the FDA’s top lawyer under President George W. Bush, noted that while the commissioner has broad discretion, initiatives not codified into law are ephemeral. "If you live by the press release then you die by the press release," he said, suggesting the next administration could swiftly dismantle the scheme. For now, it represents a fundamental and contentious shift in how America's premier drug regulator operates.
