A plan at the U.S. Food and Drug Administration to speed up certain drug reviews through Commissioner Marty Makary’s “National Priority Voucher” program has triggered concerns inside the agency about legality, staffing morale and how key decisions are made, according to an Associated Press report published Jan. 16.

The AP said the fast-track effort, which Makary has tied to “U.S. national priorities,” aims to “cut red tape” while “challenge assumptions” at the agency responsible for assuring the safety of food, medicines and medical devices. But the report describes worry among FDA staffers and outside experts that the program’s definition and process are poorly defined and could move major approval calls away from career scientists and toward political leadership.

One focus of the AP’s reporting centers on legal authority inside FDA. The AP said top officials have legal concerns about signing off on drugs cleared under the voucher pathway, citing “several people with direct knowledge of the matter” who spoke anonymously because they were not authorized to discuss confidential agency matters. The AP reported that the FDA’s then-drug director, Dr. George Tidmarsh, declined to sign off on approvals under the pathway and later resigned in November over a lawsuit challenging his conduct on issues unrelated to the voucher program.

After Tidmarsh’s departure, Dr. Sara Brenner, the FDA’s principal deputy commissioner, was set to be the final decider, but the AP reported she also declined the role after looking further into the legal issues. The AP said the deputy chief medical officer, Dr. Mallika Mundkur, is taking on the responsibility for the approval sign-off decisions described in the report.

The AP said approval decisions carry significant legal weight, describing the act of giving final approval as essentially certifying that a medicine’s safety and effectiveness meet FDA standards and noting that investigations or lawsuits could follow if unexpected side effects or other problems later emerge.

The report also describes turmoil inside the agency’s drug center, including anxiety, fear and confusion that staff associate with faster approvals. The AP said the push for quicker reviews has become part of an atmosphere inside FDA’s drug center at a time when the center has lost nearly 20% of its staff to recent layoffs, buyouts, retirements and resignations. It also said concerns about the legality of the program have contributed to the recent departure of several leaders of the drug center and that the center is being led by its fifth director in the past year.

Traditionally, the AP said, FDA drug reviews have been handled by FDA career scientists who spend months analyzing data to determine whether drugs meet federal standards for safety and effectiveness. Under the voucher program, the AP reported, approval comes through a committee vote by senior agency officials, with staff reviewers not receiving a vote—an arrangement some current and former staffers described as flipping FDA precedent by minimizing the role of scientists with the greatest expertise and familiarity with the underlying data.

The AP further reported that some staffers say they are under pressure to skip steps because the program’s workings are ambiguous, including how timelines are expected to run. It described a situation involving Eli Lilly’s anti-obesity pill in which company executives initially told FDA they expected approval within two months, according to two people involved in the review, and described why that timeline alarmed reviewers because it did not include the agency’s standard 60-day prefiling period when staff check an application for missing essential information.

The AP said Lilly pushed for a quicker filing turnaround, demanding one week, and that the agency and company eventually agreed to a two-week period. The AP also reported that when reviewers raised concerns about gaps in the application, one person involved in the process said a senior FDA official told them it was “OK to overlook the regulations if the science is sound,” and that HHS spokesman Andrew Nixon declined to comment on the specifics but said FDA reviewers can “adjust timelines as needed.”

In parallel, the AP said the voucher program has been intertwined with White House efforts to secure pricing concessions for drugmakers. The report said pricing concessions announced by President Donald Trump, a Republican, have repeatedly been paired with FDA vouchers for drugmakers who agree to cut their prices, and it described one example in which staffers had to scramble to vet and announce vouchers for Eli Lilly and Novo Nordisk for their obesity drugs in time for a press conference after the White House announced the companies would reduce prices.

The AP said that pattern has fueled concern among some staffers that FDA drug reviews have become malleable and open to political interference. It also reported that Lilly CEO David Ricks told attendees at a health care conference on Tuesday that the company expects FDA approval of its pill in the second quarter of the year.