FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI

Days after President Donald J. Trump issued an executive order (EO) curtailing diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, the FDA removed previously issued draft guidance on diversity in clinical trials from its website.1 The move, made without public notice or explanation, was noted by the public on January 23, 2025, raising concerns about the agency’s stance on clinical trial diversity requirements and the statutory obligations of sponsors as the news spreads.

President Donald J. Trump

While the deleted guidance was still in draft form, it is highly unusual for the FDA to revoke or alter draft guidance without issuing a formal announcement, according to a statement from Crowell & Moring LLP. Typically, draft guidance provides sponsors with insights into the agency’s current thinking on best practices for clinical trial design, statistical analysis, and regulatory expectations. Without this document, sponsors are left with uncertainty about how the agency will evaluate Diversity Action Plans required under the Food and Drug Omnibus Reform Act (FDORA), particularly as the statutory deadline for final guidance approaches on June 26, 2025.

Recommendations From the Now-Removed Guidance

The guidance released in June 2024 aimed at improving the enrollment of participants from historically underrepresented populations in clinical studies involving drugs, biological products, and medical devices.2 The agency draft mandated that sponsors submit Diversity Action Plans (DAPs) as part of their investigational new drug (IND) applications or premarket submissions, aligning with the regulatory framework established under sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act.

According to the FDA, diversity in clinical trials is not just a regulatory requirement; it is essential for producing reliable data that reflects the varied demographics of the population that will ultimately use these products. Clinical studies that include diverse participants are more likely to yield results that are applicable to the entire patient population.

Key Elements of Diversity Action Plans for IND

Under sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, the DAPs would be required to detail:

• enrollment goals specific to their clinical studies, disaggregated by race, ethnicity, sex, and age group of the clinically relevant population to ensure that different demographic factors are appropriately represented in the study cohort
• rationale for goals explaining the significance of these targets in terms of the study's objectives and outcomes
• strategies for meeting goals where sponsors would outline the methods to be employed to achieve these enrollment and retention goals, including community engagement, cultural competency training for researchers, and targeted outreach to underrepresented populations

Addressing Race, Ethnicity, Sex, and Age Group Diversity

The FDA's guidance was specific in its call for sponsors to consider and implement strategies that focus on:

• race and ethnicity for reporting and understanding racial and ethnic categories to create a more inclusive environment and improve the quality of the data collected during studies
• sex, as recognized in prior guidance documents, to acknowledge the imperative of including both male and female participants and ensuring that the findings are valid across different genders, including diverse gender identities
• representation of diverse age groups, particularly in pediatric studies, where the health needs and responses to treatments can differ significantly across age

Implementation of Strategies

The FDA recommended that sponsors proactively identify barriers that may hinder participation and address these within their DAPs. Effective strategies may include:

• community engagement and collaboration with health advocates and local providers to raise awareness and build trust among potential participants
• cultural competency training to ensure that clinical trial staff are equipped to communicate effectively with a diverse population, which can improve participant interactions and reduce biases
• flexibility in study design, adapting eligibility criteria to broaden access for a more inclusive participant pool.

Health and Industry Implications

The final guidance was stated to be legally due by June 2025, but with the draft guidance now missing from the FDA website, uncertainty looms over whether the agency will meet this deadline and how sponsors should proceed in the interim.1

Given the historical underrepresentation of women, intersex individuals, and those with differences in sex development in medical device trials, the guidance aimed to improve research inclusivity and the generalizability of clinical findings by ensuring diverse participant representation.

One example revealing the detriment of revoking such guidelines can be seen in cardiovascular disease, the leading cause of death in the US, which historically focused research on men’s health.3 Vast research has shown that women were systematically underrepresented in cardiovascular clinical trials, resulting in treatments and guidelines being developed without fully understanding how heart disease affects women differently.

In 1977, the FDA issued guidelines that exacerbated this disparity by discouraging the participation of women of childbearing age in clinical trials due to concerns about potential harm to fetuses. As a result, sex-specific differences in cardiovascular disease went largely unstudied; the impact is still felt today.

What Now?

The sudden removal of the draft guidance leaves sponsors with significant uncertainty regarding clinical trial diversity expectations.1 Although FDORA mandates that sponsors submit Diversity Action Plans only after FDA finalizes its guidance, many sponsors have already begun voluntarily incorporating these plans into their submissions, Crowell stated. A recent FDA report to Congress indicated that hundreds of drug and device sponsors have proactively submitted diversity plans, recognizing their importance in evaluating product safety and effectiveness.

The move also raises concerns about whether the FDA will meet its statutory deadline for final guidance. Given the executive order’s broader restrictions on DEI efforts, stakeholders are left questioning whether the agency will uphold its prior commitments to diversity in clinical research or whether further policy shifts may be forthcoming.

As industry leaders and policymakers await clarification, the firm noted that the removal of this guidance signals a shift in how regulatory agencies interpret and enforce diversity-related requirements in clinical trials under the current administration.

References

1. After Trump executive orders, FDA removes diversity guidance from website. Crowell & Moring LLP. News release. January 27, 2025. https://www.crowell.com/en/insights/client-alerts/after-trump-executive-orders-fda-removes-diversity-guidance-from-website

2. FDA. Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies. Guidance document.

3. Klein H. Why are we still seeing gaps in women’s heart care? AJMC. October 15, 2025. Accessed January 31, 2025. https://www.ajmc.com/view/why-are-we-still-seeing-gaps-in-women-s-heart-care-