FDA Quietly Rewrites Clinical Trial Guidance, Removing Mentions of DEI — What You Need to Know

In early 2025, the U.S. Food and Drug Administration (FDA) made a significant and controversial shift in how it handles guidance related to participation in clinical trials and the evaluation of sex differences in medical research. Key draft guidance documents that had previously included explicit language about diversity, equity, and inclusion (DEI) were removed or revised to strip out those references, triggering concern across the clinical research community. AJMC+1

What Changed?

At the start of the year, the FDA’s website hosted a set of draft guidance documents that industry sponsors, researchers, and patient advocates had been closely watching:

• Draft Guidance on Diversity Action Plans (DAPs) — required under the Food and Drug Omnibus Reform Act (FDORA) to help improve enrollment from underrepresented populations in clinical trials. U.S. Food and Drug Administration

• Draft Guidance on Sex- and Gender-Specific Data Evaluation — which recommended that sponsors consider sex and gender influences when designing and analyzing clinical studies. Arnold & Porter

• Guidance on Enhancing Participation in Clinical Trials — covering eligibility criteria and enrollment practices to improve the representativeness of study populations. U.S. Food and Drug Administration

By late January 2025, several of these documents — especially the diversity guidance and the sex-and-gender guidance — had been removed from the FDA’s public guidance repository without formal announcement or explanatory notice. AJMC

Some pages related to diversity and LGBTQ+ health information were also scrubbed from the FDA site, though it’s not clear whether all are permanently withdrawn. MedTech Dive

Why It Happened

The timing of the guidance removals closely followed a series of executive orders from the White House aimed at curbing federal DEI programs and eliminating references to gender identity in federal policies. These orders included directives to recognize only biological sex (male and female) and to purge federal policies or guidance that promoted or referenced broader DEI concepts. crowell.com

While the FDA did not issue a public justification at the time of removal, observers have tied the action to this broader political directive — even though neither the executive orders nor the FDA explicitly stated that the guidance was withdrawn because of its DEI language.

What Was Removed or Revised

Here’s a closer look at the key shifts:

• Diversity Action Plan Guidance:
  A draft guidance required by statute under FDORA was taken down, creating uncertainty about how or whether the FDA will enforce diversity action plan requirements. Normally, such guidance helps sponsors plan and justify efforts to include representation by sex, race, ethnicity, and other demographic factors. U.S. Food and Drug Administration

• Sex and Gender Guidance:
  Draft guidance recommending that sponsors collect and analyze sex- and gender-specific data — and consider how treatment effects might vary — was also removed from public view shortly after publication. This included recommendations on enrollment strategies and analytical approaches that many in industry expected to influence future trial design. Arnold & Porter

• Clinical Trial Participation Guidance:
  Already-existing documents on enhancing participation — which consider demographic attributes including sex, race, ethnicity, and age — remain on the FDA website, but the shift away from explicit DEI framing has left industry watchers uncertain about the FDA’s future emphasis. U.S. Food and Drug Administration

Industry Reaction and Concerns

The removal and revision of these documents has raised several concerns among sponsors, researchers, and advocates:

• Regulatory Uncertainty:
  Clinical trial sponsors rely on FDA guidance to understand expectations for study design, recruitment, and analysis. Removing draft guidance without replacement introduces ambiguity — especially for diversity action plans tied to statutory requirements. AJMC

• Impact on Representative Enrollment:
  Critics worry that without clear, updated guidance encouraging the inclusion of underrepresented groups, clinical trial populations could become less representative of real-world patients — undermining the generalizability and safety of medical treatments for diverse communities.

• Scientific and Ethical Implications:
  Diversity in clinical trials isn’t just a policy preference; it’s a scientific necessity. Historically, women and minority populations have been underrepresented in research, leading to gaps in understanding how treatments work across different groups. Removing emphasis on addressing these gaps could have broad implications for medical evidence quality. AJMC

What Comes Next

As of late 2025, the situation remains in flux:

• Future FDA Guidance:
  It’s unclear whether the FDA will reissue revised guidance that aligns with current policy directives or revert to stronger, evidence-based recommendations on diversity and sex-specific data. The comment period on some draft guidances remains open or expired without finalization. Arnold & Porter

• Legal and Policy Pressure:
  In similar instances earlier in 2025, courts have intervened to halt removals of health agency web content. Whether future litigation will affect these clinical trial guidance decisions remains to be seen. agencyiq.com

• Industry Preparedness:
  Sponsors and clinical operations teams must monitor regulatory developments closely, engage in public comment periods, and continue applying best practices for representative enrollment, even in the absence of clear guidance.

Conclusion

The FDA’s decision to remove and revise clinical trial guidances that included DEI language marks a significant shift in regulatory tone and emphasis. While the long-term regulatory consequences are still unfolding, the immediate effect has been greater uncertainty about how diversity and sex differences will be accounted for in clinical research moving forward. For sponsors, researchers, and patients alike, staying informed and adaptable will be critical as the regulatory landscape continues to evolve.