Legal questions swirl around FDA’s new expedited drug program, including who should sign off

FDA’s Expedited Drug Approval Program Raises Scientific and Ethical Concerns

The Food and Drug Administration’s new fast-track drug review system, championed by Commissioner Marty Makary, has triggered widespread alarm among agency staff who worry the program undermines established scientific protocols and opens the door to political influence in drug approvals.

The Commissioner’s National Priority Voucher program promises to approve certain medications in as little as one month—a dramatic acceleration from the agency’s standard six-to-ten-month review process. According to seven current and former FDA staffers who spoke on condition of anonymity, the initiative has intensified anxiety among an agency workforce already destabilized by layoffs, buyouts, and leadership turnover.

“The concept of doing a review in one to two months just does not have scientific precedent,” said Dr. Aaron Kesselheim, a professor at Harvard Medical School. “FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn’t have the resources to do it.”

The program has grown rapidly from its initial framing as a five-drug pilot to 18 vouchers awarded, with more under consideration. This expansion has placed additional strain on the FDA’s drug review division, which has lost approximately 20% of its staff over the past year through retirements, buyouts, and resignations.

Unlike the agency’s other expedited review pathways—all congressionally authorized with formal regulations—the voucher program exists primarily on an FDA website with minimal documented procedures. Companies can apply with a brief 350-word “statement of interest,” raising questions about transparency and oversight.

A Health and Human Services spokesman defended the program, stating it prioritizes “gold standard scientific review” while delivering “meaningful and effective treatments and cures.” However, critics argue the program lacks clear standards and appears vulnerable to political pressure.

The voucher system has become particularly prominent in White House announcements. When the administration secured pricing concessions from pharmaceutical giants Eli Lilly and Novo Nordisk on popular obesity medications, FDA staff scrambled to process new vouchers for both companies in time for President Trump’s press conference.

“It’s extraordinary to have such an opaque application process, one that is obviously susceptible to politicization,” said Paul Kim, a former FDA attorney who now works with pharmaceutical clients.

The program has created confusion regarding who has legal authority to approve drugs under the expedited pathway. Traditionally, approval decisions have been made by FDA review scientists and their immediate supervisors—not political appointees or senior leadership.

This uncertainty reportedly led the FDA’s former drug director, Dr. George Tidmarsh, to decline signing off on approvals through the program before his resignation in November. Principal Deputy Commissioner Sara Brenner similarly declined the role after examining the legal implications. Currently, Dr. Mallika Mundkur, who serves under the FDA’s top medical officer Dr. Vinay Prasad, has assumed this responsibility.

The approval process itself represents a significant departure from FDA norms. Under standard procedures, drug office directors make approval decisions in consultation with review teams. The voucher program, however, determines approvals through committee votes by senior agency leaders, with staff reviewers excluded from voting.

“It is a complete reversal from the normal review process, which is traditionally led by the scientists who are the ones immersed in the data,” Kesselheim noted.

Some FDA reviewers report being instructed to skip regulatory steps to meet aggressive deadlines. In the case of Eli Lilly’s anti-obesity pill review, company executives initially expected approval within two months—a timeline that alarmed reviewers because it bypassed the standard 60-day prefiling period that has been standard practice for over three decades. After negotiations, a compressed two-week period was agreed upon.

According to one person involved in the process, when reviewers raised concerns about missing chemistry data in the application, a senior FDA official told them it was acceptable to overlook regulations if the science seemed sound—an approach experts say contradicts fundamental FDA review principles.

Dan Troy, who served as the FDA’s top lawyer under President George W. Bush, believes the commissioner has broad discretion to reorganize drug reviews. However, he acknowledges the program may be short-lived without formal codification. “If you live by the press release then you die by the press release,” Troy said. “Anything that they’re doing now could be wiped out in a moment by the next administration.”

The program’s future remains uncertain, particularly after Reuters reported that FDA officials have delayed reviews for two drugs in the program partly due to safety concerns, including a patient death.

As former reviewers and outside experts note, the current approach may carry risks for both public health and pharmaceutical companies if future FDA leadership determines drugs weren’t properly evaluated. “They are fundamentally changing the application of the standards, but the underlying law remains what it is,” Kesselheim concluded.