The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business risk and opportunity. Understanding key 2025 trends will be critical to developing regulatory strategies and maximizing opportunities for success.
After Donald Trump entered the White House in January 2025, changes at the FDA began to come quickly. In addition to massive workforce cuts and unprecedented leadership turnover, the administration’s agenda has created a seesaw dynamic of deregulation in some areas and aggressive new scrutiny in others.
A New Guard
In 2025, the FDA saw a historic leadership exodus that is likely to cause the most significant reshaping of agency direction in decades. The directors of the FDA’s drug, biologics, veterinary medicine and tobacco centers have departed, as have many key deputies and the heads of other programs.
Already, new leaders are making dramatic breaks from their predecessors, such as Vinay Prasad’s swift change in approach to COVID-19 vaccines after being named to head the biologics center. Top political leadership at the FDA and its parent, the Department of Health and Human Services (HHS), also appears to be actively involved in other product- or class-specific decisions, such as potential labeling changes for acetaminophen.
While these shifts make many FDA decisions less predictable, they also create unique opportunities to advocate for new regulatory approaches. Companies should assess their pending and planned submissions to the agency with this landscape in mind.
Targeted Deregulation
In February 2025, Trump issued an executive order mandating that for each new “regulation” (defined to include guidance), agencies must eliminate 10 others. Although some worried this move could dramatically reduce the output of updated FDA recommendations, the agency continued to issue new guidance documents in 2025. It also increasingly used other means, such as journal articles published on accelerated timelines, to announce new policies.
Several new initiatives aim to reduce regulatory burden, including a roadmap to eliminate animal testing in preclinical studies, removal of the Risk Evaluation and Mitigation Strategies (REMS) for six CAR T cell therapies, and draft guidance indicating that many biosimilars will no longer require comparative efficacy studies for approval.
However, the FDA’s overall deregulatory message has been coupled with increased regulatory scrutiny in areas prioritized by HHS Secretary Robert F. Kennedy Jr. For example, as part of its “crackdown” on direct-to-consumer (DTC) drug advertising, the FDA announced that it will pursue rulemaking to require full provision of risk information in broadcast and digital ads, unsettling its longstanding approach.
Disruption of the status quo in favor of tightened regulatory controls also extended to the food industry. Following a directive from Secretary Kennedy, the FDA is working on a rulemaking to mandate notification for ingredients claimed to be generally recognized as safe (GRAS), while many states are simultaneously passing legislation to restrict food chemicals or “ultraprocessed” foods, especially in school meal programs. This could quickly create a patchwork of inconsistent state requirements, making compliance far more complex.
Speeding Development and Review Amidst Staffing Losses
FDA Commissioner Marty Makary has focused on speeding medical product development and review, starting with the rollout of “Elsa”, a generative AI tool meant to boost scientific review efficiency. The FDA has since announced multiple pilot programs and initiatives for products and companies aligned with the administration’s goals, such as onshoring, accelerating cures and curbing drug costs.
These include the Commissioner’s National Priority Review Voucher pilot that offers accelerated review, the PreCheck program aimed at reshoring manufacturing, and the “plausible mechanism” pathway for personalized therapies. These programs could meaningfully benefit a select group of eligible drug and biologic companies but do not address other types of products and may divert staff from reviewing “standard” submissions.
While staff losses have affected some review teams more than others, 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 numbers make it difficult to see how the FDA can avoid productivity gaps, even with AI efficiency gains.
Unprecedented Transparency
As part of its “radical transparency” push, the FDA began releasing complete response letters (CRLs) shortly after issuance. Historically, these letters—which detail the deficiencies identified by the FDA in a drug or biologic application—were not disclosed before the underlying product was approved. While often heavily redacted, the newly public letters reveal far more than the FDA has typically released outside the context of an advisory committee meeting on a specific company’s application.
Drug and biological product manufacturers should carefully consider their disclosure and communication strategies before submitting a new application, with the expectation that any CRL they receive will become public. Expanding the “radical transparency” initiative in other areas may also prompt the FDA to proactively release categories of documents that have typically been available only through FOIA requests.
Developments To Watch for in 2026
With this backdrop, biopharma has much to look out for in the coming year, including:
Review Goal Performance: When the FDA releases its annual user fee reports for FY 2025, look for any trends in review times. Consistent signs of slower FDA reviews will be a strong indicator that staffing levels are insufficient and that companies need to build more cushion into their planned timelines.
User Fee Negotiations: Negotiations between the FDA and industry representatives over the prescription and generic drug, medical device and biosimilar user fee programs are underway, and draft “commitment letters” for each program should be released by the fall of 2026. The letters will be a key window into new initiatives—like increased fees for foreign establishments—and changes to review goals and processes for 2028–2032. In addition, significant White House or HHS involvement in the user fee negotiations will clearly signal that officials within higher levels of the administration intend to take a much more active role in managing FDA affairs than the historical norm.
Continued Onshoring Emphasis: With tariff policies in flux, rising cost pressures may accelerate strategic shifts in manufacturing geography, despite efforts to seek tariff relief through delays and exemptions. Expect the FDA to maintain its push for supply chain resiliency, including through additional onshoring incentives—which the agency is already pursuing as part of the user fee negotiations—and increased scrutiny of foreign manufacturing.
AI Surveillance of Product Promotion: In announcing its DTC advertising crackdown, the FDA noted its use of AI tools “to proactively surveil” drug ads. Use of such tools will likely expand to other areas, such as promotion of medical devices and tissue products, but it remains to be seen whether this initial crackdown will have a lasting impact on DTC advertising practices or FDA’s compliance approach. Companies should nevertheless review their product-related content, including on their own social media channels and those of any paid influencers, in anticipation of increased FDA scrutiny.
Editor’s note: A version of this story was first published last month in Polsinelli’s “Life Sciences Spotlight,” a collection of articles written by attorneys on life sciences trends.
