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The Associated Press reported that turmoil is growing around the FDA’s new fast-track “National Priority Voucher” program, with some agency staffers and outside experts questioning whether expedited approvals are being handled in a way that preserves the FDA’s traditional science-first approach. The report said some concerns have extended to what legal authority FDA leaders have to sign off on approvals under the pathway and how the program fits with the White House’s drug pricing push.
According to the AP, the voucher program—described by FDA Commissioner Marty Makary as a way to “cut red tape” and “challenge assumptions” to deliver ultra-fast reviews for drugs aligned with “U.S. national priorities”—has become the focus of anxiety inside the FDA’s drug center. The report said some staffers also link the initiative to a broader environment of fear and confusion, citing recent staff losses in the drug center.
The AP said questions about the legality of the program have contributed to departures among senior leadership at the FDA’s drug center, which is now being led by its fifth director in the past year. The report described agency turnover that, in turn, has increased pressure on whoever is tasked with making or overseeing final decisions under the expedited pathway.
The AP reported that top FDA officials have raised legal concerns about signing off on expedited approvals under the Commissioner’s National Priority Voucher program. According to the report, several people with direct knowledge said on condition of anonymity that the issue is who has the appropriate legal authority to approve drugs cleared under the program.
The AP said the FDA’s then-drug director, Dr. George Tidmarsh, declined to sign off on approvals under the pathway and later resigned in November, describing that resignation as occurring over a lawsuit challenging his conduct on issues unrelated to the voucher program. After Tidmarsh left, the AP said Dr. Sara Brenner, then the FDA’s principal deputy commissioner, was set to be the final decider but also declined after looking further into the legal issues, according to the people familiar with the matter. The AP reported that the responsibility is now being taken on by Dr. Mallika Mundkur, the FDA’s deputy chief medical officer.
The AP also described the stakes of that decision-making authority, saying that giving final approval carries significant legal weight—effectively certifying that a medicine’s safety and effectiveness meet FDA standards. The AP report said that, if problems later emerge, both the agency and individual officials could face investigations or lawsuits.
In the AP report’s description of how the voucher approvals are being structured, the traditional role of FDA career scientists is being reduced. The AP said FDA approval decisions have typically been handled by FDA career scientists and their immediate supervisors, rather than political appointees and senior leaders. By contrast, the AP reported that, under the voucher program, approvals come through a committee vote by senior agency officials and that staff reviewers do not get a vote.
The AP said staff reviewers have also faced pressure to skip steps amid ambiguity about how the voucher program works. It reported that, because the pathway’s workings were unclear, some drugmakers interpreted their own review timelines in ways that alarmed FDA reviewers. The AP cited the example of Eli Lilly’s anti-obesity pill review, where two people involved said company executives initially told the FDA they expected approval within two months, a timeline that did not include the agency’s standard 60-day prefiling period during which staff check applications for missing essential information.
The AP reported that Lilly pushed for a quicker filing turnaround, demanding one week, and that the agency and company eventually agreed to a two-week period. The report said, when reviewers raised concerns about gaps in the application, one person involved in the process said they were told by a senior FDA official that it was acceptable to overlook regulations if the science was sound. The AP said FDA spokesman Andrew Nixon declined to comment on the specifics of the Lilly timeline but said FDA reviewers can “adjust timelines as needed,” and it reported that Lilly’s CEO, David Ricks, told a health care conference on Tuesday that the company expects FDA approval of its pill in the second quarter of the year.
The AP said the voucher program’s link to politics is not confined to internal process changes, but also connected to how the White House frames drug pricing. It reported that the program has remained popular at the White House, where pricing concessions announced by President Donald Trump have repeatedly been paired with FDA vouchers for drugmakers that agree to cut their prices.
The AP gave an example involving Eli Lilly and Novo Nordisk A/S, saying that when the White House announced price reductions for their obesity drugs, FDA staffers had to scramble to vet and announce new vouchers for both companies in time for a press conference. The AP report said that practice has raised widespread concern that FDA drug reviews are becoming malleable and open to political interference—an outcome staffers and outside experts fear could harm the FDA’s reputation and endanger patients.
Health and Human Services spokesman Andrew Nixon, in the AP report, said the voucher program prioritizes “gold standard scientific review” and aims to deliver “meaningful and effective treatments and cures.” The AP report did not indicate whether the FDA’s program will change, but it portrayed the present approach as generating uncertainty about legal sign-off and about how much authority the FDA’s scientific reviewers retain when drugs are pushed through expedited pathways.