Layoffs and other staff reductions at the US Food and Drug Administration are a “slow-moving catastrophe” that will undermine drug approvals in subtle ways, former Principal Deputy Commissioner Janet Woodcock said.
The “whole apparatus to get a drug on the market has been undermined,” Woodcock said 7 April at the Biopharma Congress, presented by Prevision Policy and Friends of Cancer Research.
Woodcock, the longtime Center for Drug Evaluation and Research director who also was acting commissioner, retired in 2024.
She was frank in discussing the impact that the FDA’s downsizing will have on medical product development and approvals, including the loss of agency leaders to mediate internal disputes over applications.
She also compared the Trump Administration’s early impact on the FDA to allowing people who believe the Earth is flat to take over the National Aeronautics and Space Administration.
Focusing On IND Reviews, Applications
On 1 April about 3,500 FDA staff received reduction-in-force notices as part of the Health and Human Services Department’s broader downsizing and restructuring effort. Although reviewers and inspectors were not targeted, the RIFs impacted many administrative and other staff who support review and inspection activities, including project managers, regulatory counsels and policy experts.
The medical product center-based staff that plan advisory committee meetings also were deeply impacted, and meeting cancellations are expected.
The layoffs came after many probationary employees were fired and other staff participated in deferred resignation and retirement incentive programs. More than 1,000 people have left CDER since the beginning of January.
The agency’s leadership ranks also have been gutted under the Trump Administration.
CDER Director Patrizia Cavazzoni retired just days before President Trump’s inauguration. Center for Biologics Evaluation and Research Director Peter Marks resigned in late March due to a dispute with HHS Secretary Robert F. Kennedy Jr. on vaccine safety.
Other high-profile departures include Office of New Drugs Director Peter Stein, CBER Deputy Directors Celia Witten and Julie Tierney, Oncology Center of Excellence Deputy Directors Paul Kluetz and Marc Theoret, and Lola Fashoyin-Aje, director of the Office of Clinical Evaluation in CBER’s Office of Therapeutic Products.
With the staff thinned, remaining personnel will focus on “certain things that are really important,” including reviewing investigational new drug applications for safety issues and pending product applications, Woodcock said.
Giving drug development advice to sponsors likely will fall by the wayside, Woodcock said. Also lower on the list is developing guidance, “especially when they don’t know if any guidance would ever be allowed to be released,” she said.
Internal Disagreements Will Cause Slow Downs
The “decapitation” of agency leadership means there are few people remaining to settle disagreements among review staff about product applications or other scientific issues, Woodcock said.
“There’s disputes amongst the staff about what to do,” she said. “That’s why some of the management has to be technical managers who are experienced reviewers, experienced scientists, experienced doctors who can mediate that.”
“I spent a huge amount of time doing [that], because the disciplines will fight with each other, the different reviewers have different opinions,” Woodcock added. “There’s a lot of uncertainty in the development of medical products.”
Woodcock predicted there will be “mysterious slow-downs, and you won’t know what it’s about.”
“It’s about the agency doesn’t have any more smooth mechanism to sort out all these disputes,” she said.
Although inspectors remain in place, the staff who scheduled those inspections have been cut. If inspectors can’t get to a facility, reviewers are “going to be really reluctant to just go ahead and approve a product from an unknown” entity, she said.
Rare Disease Impacts
Attorney Frank Sasinowski, a director at Hyman, Phelps and McNamara in Washington, DC, predicted the staffing reductions will disproportionately affect rare disease drug development, including the loss of agency leaders who were willing to take a risk on accelerated approval or who encouraged flexibility in study designs.
Sasinowski also said half of all NDAs are 505(b)(2) applications, which often raise nuanced regulatory and legal questions requiring the expertise of staff who were laid off.
Without internal experts who provided advice and the confidence to move forward, reviewers likely will take a conservative approach, which could close the accelerated approval pathway and repurposing of drugs through 505(b)(2) applications, he said.
However, Sasinowski reiterated the remaining division and office directors in CDER and CBER are committed to try to stay the course. He specifically cited OTP Director Nicole Verdun.
“They’re steely-eyed determined to do what’s right for the American public,” he said.
However, “when everything else around them has been stripped, how long can they continue to function and to meet their objectives and do it in a high-quality way without having other resources to draw on?” Sasinowski said.
The Flat Earth Society
Woodcock was blunt in her assessment of the Trump Administration’s early impact on FDA staff and morale.
“My best analogy is this is like the flat Earthers taking over NASA,” she said. Once in charge, the “first thing they do [is] they fire everyone who disagreed with them and said the Earth was round.”
“The next thing they do, they’re going to purge any round Earth ideology out of NASA,” Woodcock said. “And the third thing they’re going to do, they’re going to go up to the space shuttle and throttle those people who are sending back false pictures.”
“You all have been very polite about this, but this is actually what’s going on,” she said. “It’s really beyond the pale … It is not science. And this is a science-based regulatory agency, which means legal and science, and these messages they are getting are not about science. These changes, these purges, these proposed reorganizations, this is not about management or leadership.”
