Key Takeaways
- Industry is starting to quietly raise concerns that the FDA's productivity is slowing due to the administration change.
- While most current complaints are minor, with more staff expected to leave voluntarily or through layoffs, fears of missed user fee deadlines are growing.
- One source said the number of complete response letters for drugs and biologics has increased, but the exact cause of the rejected applications is difficult to know.
The Trump Administration’s changes at the US Food and Drug Administration, including voluntary and involuntary staff reductions and return-to-office mandates, are starting to negatively impact industry, multiple sources working with medical product companies told the Pink Sheet.
FDA staff are slower to respond to calls and emails, missing some deadlines, less organized, less accessible and less predictable, sources said.
Sources inside and outside the agency fear product review delays soon may emerge due to the smaller and demoralized workforce. Many FDA staff are openly looking for new positions, including in industry, and a loss of hard-to-replace expertise is expected.
“I’ve already heard from industry concerns,” Janet Woodcock, former FDA acting commissioner and long-time career staffer, told the Pink Sheet. “They’re not getting things on time. They feel like there’s a lot of delay.”
Woodcock, who described current staff as “terrorized,” said the situation will be difficult for expected new commissioner Marty Makary to correct.
“He’ll be expected to perform, the agency will be expected to perform, but if they’re systematically dismantling [the FDA] or demoralizing everybody or not giving them proper working conditions, it’s going to deteriorate, and people will continue to leave and no one will come,” Woodcock said. “Because who would join a program like that?”
Conditions May Mean More Complete Responses
In the first two months of the Trump presidency, the FDA already has laid off, and rehired, some staff, and has broader plans for future involuntary staff reductions. The Trump Administration also instituted early retirement and buyout programs to encourage voluntary attrition and imposed a hiring freeze.
On 17 March most FDA staff returned to in-office work, which forced many into unpleasant working conditions and lengthy commutes. Agency sources said the situation already is impacting staff productivity and retention.
Other Trump Administration actions, including adding new barriers to conduct research or communicate outside the agency, limiting work travel and meetings, and eliminating work on diversity, equity and inclusion, are causing staff efficiency and morale to suffer.
More new drug applications (NDAs) and biologics licensing applications (BLAs) are receiving complete response letters, said Bob Pollock, senior advisor and outside director to the board of Lachman Consultants, based on data he has seen and reports from those with which he is working.
Pollock, who worked at the FDA earlier in his career, including as the acting deputy director of the Office of Generic Drugs, said generic drug approvals remain at their normal pace. But if project managers took the administration’s $25,000 buyout, abbreviated new drug application (ANDA) reviews almost certainly will stall, which could reverse gains made by the generic drug user fee program and set the FDA back by 20 years, he said.
Device, Veterinary Centers Also Fear Slowdowns
Other FDA product divisions are facing similar challenges.
The Center for Veterinary Medicine has been telling sponsors not to expect the agency to finish reviews early.
In the medical device space, an agency source told the Pink Sheet that their group has not missed deadlines, but likely will soon, given the loss of key staff, particularly medical doctors, and the overcrowded office environment.
The agency’s White Oak headquarters was described as loud and chaotic and filled with staffers stressed about the stability of their jobs. Due to the conditions people said they were less willing to take their laptops home and work extra hours.
Supervisors are giving directions on prioritizing competing deadlines. For example, device employees were told to focus on investigational device exemptions (IDEs) because their FDA review is safety focused. Without agency action, an IDE is automatically approved 30 days after receipt.
The FDA did not respond to a request for comment.
Minor Industry Complaints May Become Major
This month, the FDA approved five NDA/BLAs as of 17 March. In February, 19 were approved, along with eight in January.
For drugs and biologics, the FDA has not missed any known user fee goal dates this month. However, the agency does not release goal date information and companies often do not publicize them.
A complete response letter also counts as FDA meeting its goal to act on an application, according to the user fee agreements.
The end of March is expected to be busy with upcoming user fee goals for seven new molecular entities among other applications. But the full impact of the administration’s changes on productivity may take longer to fully gauge.
Many of the people who have heard sponsors’ concerns suggested they were relatively minor, at least for now. But they indicated the concerns also may signal more troubling delays could be coming.
“The majority of complaints that I have heard to date have involved a perceived decrease in communication with stakeholders,” said John Taylor, head of quality and compliance at Eliquent Life Sciences and a former FDA acting deputy commissioner.
Taylor said scheduling meetings is difficult and industry is becoming frustrated about “who is filling jobs and who will fill them in the future.”
There is “just profound dismay over a lack of transparency and predictability regarding the agency’s functions,” he said.
However, others have seen no change in work speed.
“FDAers are resilient and seemingly stouthearted in their dedication to promoting health and touching sufferings of our sisters and brothers,” said Frank Sasinowski, a director at Hyman, Phelps and McNamara who frequently works in the rare disease space.
Bridget Silverman contributed to this report.