Former US Food and Drug Administration officials are worried that the loss of long-standing institutional expertise and politically influenced decision-making at the agency under the Trump Administration could tarnish the regulator’s reputation as a leader in cutting-edge science.
Janet Woodcock, who served as the agency’s principal deputy commissioner from 2022 to 2024 and in multiple senior leadership positions before that, and Richard Pazdur, the former director of the Center for Drug Evaluation and Research (CDER) and the Oncology Center of Excellence, said at a Friends of Cancer Research (FOCR) meeting last month that the agency is strained and expertise is lacking due to significant reductions in staff.
Last year, after President Trump took office, there were major cuts to staff across multiple government agencies, including at the FDA. The Department of Government Efficiency laid off about 1,000 FDA probationary workers last February, with a particular emphasis on those in the agency’s Center for Devices and Radiological Health (CDRH), although many of those employees were rehired after a federal judge’s order.
Then, the US Department of Health and Human Services gave notice in March of a reduction in force (RIF) that would impact up to 10,000 federal employees across its various agencies. The reduction sparked concern among reviewers in the firm’s medical device division about job security and the ability to meet product review deadlines.
Neither Pazdur nor Woodcock were included in the RIF. Pazdur abruptly resigned in December after being at the agency more than 25 years and receiving a promotion to lead CDER. The reason, he told the Wall Street Journal, was because he was asked to simply go along with the agency’s decision to require sponsors submit data from one well-controlled trial, instead of two, as has been the expectation historically. Agency leaders recently discussed this change in the New England Journal of Medicine.
Pazdur didn’t respond to a request for comment for this article. In an interview after the FOCR meeting, Woodcock, who left the FDA after 38 years in 2024, indicated that at 77, it was simply time to retire.
Both are worried about the FDA’s ability to help the US maintain its biotech leadership. For example, during a discussion on biomarker qualification at the FOCR meeting, Pazdur specifically called out the fact that “many times, the people that we need to be interacting and developing these biomarkers have left the agency.” Biomarkers are critical to advancing precision medicines and advanced diagnostics.
In a separate interview after the meeting, Woodcock said that there is still some expertise left, including in the clinical pharmacology space, in CDRH with diagnostics, and in the Office of New Drugs, but that many senior people with years of experience have left the agency. “The leadership is the group that can help people embrace … new ways of doing things,” she said. “That’s what is most at risk with losing these senior experienced people who are more comfortable with trying new paradigms.”
At the FDA, Woodcock covered the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. She also led the agency’s Critical Path Initiative, which aimed to modernize drug development by incorporating scientific advances like genomics and advanced imaging technologies into the process.
Pazdur, meantime, was responsible for launching the FDA’s Oncology Center of Excellence, which was intended to help accelerate patient access to new oncology treatments and devices by encouraging collaboration across CDER, the Center for Biologics Evaluation and Research, and CDRH. At the FOCR meeting, Pazdur acknowledged that there have been attempts to hire more people at the agency but noted that it’s “not just about hiring numbers of people, it’s the qualifications and the types of people who have left the agency.”
“And that’s going to have a profound effect as we talk about novel endpoints and other issues,” Pazdur said at the meeting, which brought together stakeholders to discuss modernizing endpoints in cancer drug trials using circulating tumor DNA and artificial intelligence-enabled tumor assessment tools.
There is a need for people with “the requisite training, with the ability to take chances,” he added.
Woodcock worries that drug approvals will slow down as that expertise dwindles. Precision medicine approvals have already slowed under the current administration’s FDA, and Woodcock said the turndowns in approvals are “concerning.”
By Precision Medicine Online’s count, the FDA last year approved 38 precision medicines, including 25 biomarker-defined treatments, three cell-based therapies, and 10 nucleic acid medicines. In 2024, 48 biomarker-targeted, autologous cell, and gene therapies were approved. These include new molecular entities and new, expanded indications of already approved drugs.
Considering only new molecular entities overall, and not just precision medicines, the FDA approved 44 such treatments, down from 50 in 2024.
“The current regime has said very confusing things” to sponsors, as they shepherd investigational treatments through the regulatory process, Woodcock added.
Woodcock specifically cited the turmoil over UniQure’s gene therapy for Huntington’s disease. UniQure previously planned to seek approval for the therapy in early 2026, but said that the FDA has walked back its previous feedback. A coalition of five Huntington’s disease nonprofit organizations have since urged the agency not to delay the therapy’s review.
It’s “very concerning that their actions are more conservative,” Woodcock added.
As a result of these types of actions and the diminishing expertise at the agency, she believes that others will have to lead the way for biomedical innovation in precision medicine, whether that be industry or the nonprofit sector. Woodcock also sees an opportunity for other countries heavily investing in new biotechnologies, like China, to surpass the US in terms of innovation.
“The science will move ahead, but the US may lag behind,” she said.
During both the FOCR meeting and the interview, Woodcock expressed additional concern that “political firewalls” at the agency, shielding its reviewers’ decisions from undue political influence, have been breached by this administration. Pazdur shared her sentiments at the FOCR meeting that the firewall “has been transgressed here and that’s going to have lasting implications.”
Woodcock said during the interview that she has heard that the review staff at the agency are being pressured to make certain decisions on products. In the past, political appointees have been limited at the FDA, and those that have been present have been in policy positions rather than making decisions on approvals, she noted. But that has changed during President Trump’s second term.
“You can build all the firewalls you want, [but] if the administration is determined and nobody’s controlling them, then that won’t work,” she said.
Pazdur is of the view that the agency should be an apolitical body and recruit experts who have been vetted based on their scientific capabilities rather than their political aspirations. These people should be “outside of the political process,” he said at the meeting.
“This is a scientific organization, it should have scientists running this,” he said of the FDA. “They should not be approved by politicians.”
The FDA that Pazdur and Woodcock worked under certainly wasn’t immune to political controversies. For example, Woodcock’s prospects to become FDA commissioner under President Biden stalled when some Senate Democrats perceived her to be too cozy with the pharmaceutical industry. During the FOCR meeting, she acknowledged that she has faced political pressure to make certain decisions during her career, but she noted that it has traditionally been the job of leaders to shield the rest of the agency staff.
While the FDA must interface with the political world, Woodcock said it must be restored to a more “hands-off approach if there’s going to be credibility [at] the agency.”