A controversial initiative to dramatically accelerate drug approvals at the US Food and Drug Administration (FDA) is fuelling significant internal turmoil, with career scientists expressing deep concerns over legal authority, patient safety, and political influence.
Legal Ambiguity and Leadership Exodus
At the heart of the discord is Commissioner Marty Makary's National Priority Voucher programme, which promises ultra-fast reviews for drugs aligning with "U.S. national priorities." However, top FDA officials have reportedly clashed over who possesses the proper legal authority to sign off on medicines cleared under this new pathway.
According to sources speaking anonymously to The Associated Press, the FDA's then-drugs director, Dr. George Tidmarsh, declined to approve drugs under the scheme before resigning in November 2025. His successor in the interim role, Principal Deputy Commissioner Sara Brenner, also refused the final approval responsibility after examining the legal questions. The duty has now reportedly fallen to Dr. Mallika Mundkur, the agency's deputy chief medical officer.
This hesitation stems from the significant legal weight of final drug approval, which certifies a medicine's safety and efficacy. Officials fear they could face personal liability in future lawsuits if unforeseen side effects emerge from hastily approved treatments.
Political Pressure and Eroded Scientific Process
Compounding the legal worries is the programme's deep entanglement with White House efforts to secure drug pricing concessions. The AP reports that FDA vouchers have repeatedly been announced alongside price-cut pledges from pharmaceutical companies, a departure from the agency's traditional science-first mandate.
For instance, when Eli Lilly and Novo Nordisk agreed to reduce prices on popular obesity drugs, FDA staff were allegedly forced to rapidly vet and issue vouchers for both firms in time for a White House press conference. This has sparked fears that drug reviews are becoming malleable to political interference.
Under the new system, approval decisions are made by a committee vote of senior agency officials, sidelining the career scientists and reviewers who traditionally hold this responsibility based on their direct analysis of the data.
"Overlook the Regulations": Staff Report Mounting Pressure
The push for speed is creating a climate of anxiety and confusion within the FDA's drug centre, which has lost nearly 20% of its staff to layoffs, buyouts, and resignations. The ambiguity around the fast-track process has led to conflicts with drugmakers over timelines.
During the review of Eli Lilly's anti-obesity pill, company executives initially demanded approval within two months, bypassing the standard 60-day pre-filing check. Reviewers who raised concerns about application gaps were reportedly told by a senior FDA official: "If the science is sound then you can overlook the regulations."
Former reviewers and external experts warn this approach inverts the FDA's core mission; it is through rigorous regulatory adherence that staff scientifically confirm a drug's safety and effectiveness.
While a Health and Human Services spokesman stated the programme prioritises "gold standard scientific review," the internal dissent and recent departure of several drug centre leaders—the fifth director in a year—paint a picture of an agency under unprecedented strain, with its reputation for impartial scientific judgement potentially at risk.
