After Donald Trump assumed the presidency in January 2025, the Food and Drug Administration (FDA) underwent major changes, including significant workforce reductions and leadership turnover. The administration's approach has resulted in both deregulation in some sectors and increased scrutiny in others.
In 2025, nearly all senior leaders at the FDA left their positions. According to BioSpace, "Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner." This wave of departures included directors from drug, biologics, veterinary medicine, and tobacco centers.
New leaders have quickly moved to distinguish themselves from their predecessors. For example, Vinay Prasad changed policies on COVID-19 vaccines soon after becoming head of the biologics center. Political involvement from top officials at both the FDA and its parent agency, the Department of Health and Human Services (HHS), has also influenced decisions such as proposed labeling changes for acetaminophen.
Companies interacting with the FDA are now advised to review their regulatory strategies due to these unpredictable shifts.
In February 2025, President Trump signed an executive order requiring agencies to eliminate ten regulations for every new one introduced. Despite concerns that this would slow updates to FDA guidance documents, new guidances continued throughout 2025. The agency also used alternative methods like journal articles published on accelerated timelines to communicate policy changes.
Several initiatives aimed at reducing regulatory burdens were launched last year. These include efforts to remove animal testing requirements in preclinical studies, lifting Risk Evaluation and Mitigation Strategies (REMS) for certain CAR T cell therapies, and draft guidance that could allow many biosimilars to bypass comparative efficacy studies for approval.
However, this deregulatory trend was balanced by stricter oversight in areas prioritized by HHS Secretary Robert F. Kennedy Jr., such as direct-to-consumer drug advertising. The FDA announced plans for rulemaking that would require full disclosure of risk information in broadcast and digital ads—a departure from past practices.
The food industry is also facing tighter controls. Following directives from Secretary Kennedy, new rules may soon require notification for ingredients labeled as generally recognized as safe (GRAS). States are simultaneously enacting laws restricting food chemicals or "ultraprocessed" foods in school meal programs. This could lead to inconsistent requirements across states and complicate compliance efforts.
FDA Commissioner Marty Makary has prioritized faster medical product development and review processes amid staffing shortages by introducing "Elsa," a generative AI tool designed to increase efficiency during scientific reviews. Other pilot programs include a National Priority Review Voucher initiative offering accelerated review for select products; PreCheck for reshoring manufacturing; and a “plausible mechanism” pathway focused on personalized therapies.
Despite these innovations, staff losses remain significant: "sobering FDA data from October show net losses of 1,093 employees in the drug center and 224 in the biologics center for fiscal year (FY) 2025." These reductions challenge productivity even with gains made through AI tools.
As part of its push for transparency, the FDA began releasing complete response letters (CRLs) shortly after they are issued—letters that detail deficiencies found during application reviews—which were previously not disclosed before product approval. While often redacted, these public releases reveal more than what was typically available outside advisory committee meetings.
Manufacturers are now encouraged to carefully consider their communication strategies since any CRL received will likely become public knowledge. The expansion of transparency measures could result in other types of documents being proactively released by the agency as well.
Looking ahead to 2026, several developments will be closely watched:
- Performance metrics when annual user fee reports are released may indicate whether staffing issues are affecting review times.
- Ongoing negotiations between industry representatives and the FDA over user fee programs will provide insight into possible increases in fees or changes in review goals.
- Continued emphasis on bringing manufacturing back onshore is expected due to shifting tariff policies.
- The use of AI surveillance is likely to expand beyond drug advertising into areas like medical devices; companies should prepare content accordingly as scrutiny increases.
