Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

FDA Drug Review Overhaul Raises Scientific Integrity Concerns Among Experts

A controversial plan to dramatically accelerate drug review times at the Food and Drug Administration has ignited significant alarm among agency scientists and outside experts. Critics argue that FDA Commissioner Marty Makary’s initiative, which promises expedited reviews for drugs deemed “U.S. national priorities,” is shifting crucial scientific decisions away from career scientists and into the hands of political appointees.

The initiative stands at the center of Makary’s stated mission to “cut red tape” at the regulatory agency responsible for ensuring the safety of food, medicines, and medical devices. However, agency staffers report that the push for faster approvals has created an atmosphere of anxiety and confusion within the FDA’s drug center, which has already lost nearly 20% of its workforce to recent layoffs, buyouts, retirements, and resignations.

Legal concerns about the program have reportedly contributed to the departure of several leaders from the FDA’s drug division, which has now seen five different directors over the past year. Traditionally, FDA drug reviews have involved a meticulous process where career scientists spend months analyzing data to determine whether medications meet federal safety and effectiveness standards.

The effort to accelerate certain drug approvals has become increasingly entangled with White House initiatives to secure pricing concessions from pharmaceutical manufacturers. This unprecedented shift away from the agency’s long-established science-based approach has generated fears among staff that it could damage the FDA’s reputation and potentially endanger patients.

When asked about these concerns, Health and Human Services spokesman Andrew Nixon defended the voucher program, stating it prioritizes “gold standard scientific review” while aiming to deliver “meaningful and effective treatments and cures.”

Questions about legal authority have persisted among top FDA officials regarding who has the proper jurisdiction to sign off on drugs cleared under the Commissioner’s National Priority Voucher program. Dr. George Tidmarsh, the FDA’s former drug director, reportedly declined to approve medications under this pathway before his resignation in November over unrelated issues.

After Tidmarsh’s departure, Dr. Sara Brenner, the FDA’s principal deputy commissioner, was positioned to make final approval decisions but also declined the role after examining potential legal complications. Currently, the agency’s deputy chief medical officer, Dr. Mallika Mundkur, has assumed this responsibility.

Approving drugs carries significant legal implications, as it essentially certifies that medications meet FDA safety and effectiveness standards. If unexpected side effects or other problems emerge later, both the agency and individual officials could face investigations or litigation.

Despite these concerns, the program enjoys strong support from the White House, where drug pricing announcements by President Donald Trump have repeatedly coincided with FDA vouchers for pharmaceutical companies that agree to reduce prices. When the White House revealed that Eli Lilly and Novo Nordisk would lower prices on their obesity medications, FDA staff reportedly had to rush to vet and announce new vouchers for both companies in time for the press conference.

This pattern has fueled widespread concern that FDA drug reviews have become susceptible to political influence. Under the voucher program, approval decisions now reportedly come through committee votes by senior agency officials, with staff reviewers excluded from voting. Current and former employees say this approach reverses FDA precedent by minimizing input from scientists who possess the greatest expertise and familiarity with drug safety data.

The program’s ambiguous implementation has created additional confusion, with some pharmaceutical companies developing their own interpretations of review timelines. During the ongoing review of Eli Lilly’s anti-obesity pill, company executives initially told the FDA they expected approval within two months, bypassing the agency’s standard 60-day prefiling period when staff check applications for completeness.

After pushing for a one-week turnaround, Lilly eventually agreed to a two-week period. When reviewers raised concerns about gaps in the application, one person involved in the process claimed they were told by a senior FDA official that regulations could be overlooked if the science appeared sound.

Eli Lilly’s CEO, David Ricks, recently told attendees at a healthcare conference that the company anticipates FDA approval of its weight loss pill in the second quarter of this year.

As this unprecedented overhaul continues, the tension between accelerating drug approvals and maintaining scientific integrity remains at the heart of one of the most significant shifts in FDA regulatory approach in recent memory.