When the Trump administration took office in January 2025, the Food and Drug Administration (FDA) faced a difficult transition under Health Secretary Robert F. Kennedy Jr. According to Aparna Thakur, assistant project manager of Forecasting and Analytics at DelveInsight, “The most disruptive trend by far was the massive workforce reduction early in the year.” By July, about 3,500 employees—roughly 20% of the FDA’s staff—had left.
This period saw confusion at the agency with unclear claims about vaccines, changes to regulatory guidance, and several high-level departures that impacted morale and institutional knowledge. Chad Landmon, chair of Hatch-Waxman & Biologics at Polsinelli Law Firm, commented on the abrupt retirement of Center for Research and Drug Evaluation (CDER) director Richard Pazdur just three weeks after he started: “didn’t give folks in the drug industry a lot of comfort.” Landmon added: “I think we’re all going to be looking to see who gets in that position and see if there can start being some personnel stability over at FDA.” Tracy Beth Høeg was named acting CDER chief on December 3.
Despite staffing challenges, Thakur noted positive developments under FDA Commissioner Marty Makary such as expedited reviews, improved clinical trial monitoring, artificial intelligence integration, and public release of previously confidential complete response letters. She called this move “revolutionary,” as it provided transparency into why drugs were rejected.
Thakur expressed hope for greater stability: “First and foremost,” she said, “I’d love to see the FDA return to full staffing levels and have secure, protected funding.” She added that reliable regulation is especially important for smaller companies. Thakur also praised innovation but cautioned that faster processes must remain trustworthy: “Faster is only better if it’s also trustworthy.”
Experts interviewed by BioSpace generally agreed that 2025 was a challenging year for FDA leadership. Thakur stated these disruptions led to delays in reviews and fewer guidance documents. Graig Suvannavejh from Mizuho Securities remarked: “While we totally expected 2025 to be a year of transition at FDA... I don’t think we were really prepared for . . . the mass exodus we saw in staffing at FDA.” He noted hundreds more voluntary departures beyond layoffs.
Suvannavejh highlighted instability within CDER leadership: including Høeg and Pazdur, five different people led CDER during one year. He said: “That’s five people in one year alone. It’s not acceptable.”
Landmon observed increased policy direction from HHS rather than agency autonomy under Kennedy’s leadership: “I think in the past, FDA was really given a lot of autonomy... certainly that has changed under RFK’s leadership,” he said.
Despite organizational issues, policy changes aimed at expediting rare disease drug reviews advanced during 2025. In November, the agency introduced its "plausible mechanism" approval pathway for treatments targeting very small patient populations where an underlying biological process is identified.
Stuti Mahajan from DelveInsight expects further use of this pathway: “The FDA will likely double down on [the] new fast-track approval mechanism introduced in 2025.” Mahajan also pointed out the Commissioner’s National Priority Voucher (CNPV) program launched in June which aims to reduce review times significantly—from up to a year down to one or two months—for certain products aligned with national priorities. Fifteen vouchers have been issued so far; Augmentin XR by USAntibiotics received the first approval through this route.
Mahajan anticipates more rapid market entry for voucher-holding products if successful pilots continue: “We’ll likely see some of these voucher-holding products hit the market much faster than usual...” The program could expand or add rounds based on results.
A related initiative allows approvals based on just one pivotal trial instead of two—a change met with caution by Suvannavejh who emphasized safety concerns: "Remember, the #1 mandate for the FDA is oversight of the safety of the American public."
The CNPV program also incentivizes alignment with administration priorities such as domestic manufacturing or pricing strategies consistent with President Donald Trump’s Most Favored Nation rule. Mahajan suggested this may result in regulatory speed being used as leverage for policy goals regarding pricing or supply chain needs.
Health Secretary Kennedy has influenced additional directions—including sending cease-and-desist letters over deceptive pharmaceutical advertising—and may push further regulation around nutritional claims or vaccine approvals according to Mahajan.
Artificial intelligence adoption accelerated during 2025 as well. In June, FDA launched Elsa—a generative AI assistant—to help staff access internal documents securely and prioritize tasks efficiently; agentic AI models followed later that year supporting complex tasks like pre-market reviews and compliance assessments.
Mahajan described technology filling gaps left by reduced staffing but acknowledged Elsa had early issues providing incomplete information—problems expected to improve over time leading toward broader AI use across regulatory functions such as data summarization or adverse event triage.
Industry experts expect continued AI integration both within biopharma companies’ operations and regulatory oversight—with new rules likely forthcoming around AI usage not only for development but manufacturing too—as stability remains critical following recent disruptions.
