Trump Administration’s DEI Executive Order and the impact on FDA’s DAP draft guidance: Top points

For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to increase the diversity of enrollees in pivotal clinical trials to more accurately reflect the population that will take or be administered an approved drug or device.[1]

In this alert, we discuss the status of FDA’s requirements to submit diversity action plans (DAPs), recent actions by President Donald Trump and FDA regarding these requirements, and guidance for life sciences companies as they plan and design their clinical trial programs.

Diversity in clinical trials: A background

In 2022, Section 3601 of the Food and Drug Omnibus Reform Act (FDORA) required clinical trial sponsors to submit a DAP with their study protocols, and Section 3602 mandated FDA to issue new draft guidance or update existing draft guidance on the form and matter of those submissions. Further, Section 3602 directed FDA to publish the final guidance no later than nine months after closing the comment period.  

FDA issued draft guidance for diversity action plans in June 2024, which described what should be included in a DAP for phase 3 or other “pivotal” studies for drug approval and device studies not exempt from investigational device exemption (IDE) regulations.[2]

Some key topics addressed in the draft DAP guidance include:

• DAP content requirements including (1) the sponsor’s goals for enrollment, disaggregated by age, sex, race, and ethnicity, (2) the sponsor’s rationale for such goals, and (3) the sponsor’s explanation of how the sponsor intends to achieve such goals.
  
  
• Timelines and procedures for DAP submissions to FDA.
  
  
• Procedures for requesting waivers from the DAP requirement.
  
  
• Considerations for public posting of key information pertaining to the DAP, and
  
  
• Status updates regarding the sponsor’s progress toward meeting DAP enrollment goals.

These requirements would become binding for clinical investigations, for which enrollment commenced 180 days after publication of the final guidance (which, as of this publication, has not occurred yet).  

Anticipating that this draft guidance would be finalized this year, biopharmaceutical and device companies, contract research organizations, clinical trial centers, patient groups, and others have invested in approaches to generate and implement DAPs. Many of these efforts were already underway before the diversity plan requirements were passed into law, with the Agency recognizing that diseases present differently in different people, and that data from a diverse, representative patient population could help support a more accurate assessment of the safety and efficacy of an approved product. 

Removal of DAP guidance from FDA website raises questions

As noted above, the compliance deadline for mandatory submission of diversity action plans is linked directly to FDA guidance becoming final; and, under FDORA, the draft guidance was required to be finalized nine months after the end of the comment period.  However, under an Executive Order issued on January 27, 2025, the Trump Administration ordered a pause on certain diversity, equity, and inclusion (DEI) efforts, resulting in the removal of the draft DAP guidance from FDA’s website. Following the issuance of this Executive Order, the timeline, content, and manner in which sponsors will be required to submit DAPs to FDA is uncertain for future protocol submissions. 

Robert F. Kennedy, Jr., President Donald Trump’s nominee to lead the United States Department of Health and Human Services – which oversees FDA – indicated during his confirmation hearing on January 29, 2025, that he would finalize the DAP guidance. 

How can life sciences companies navigate the uncertainty?

Although this is an evolving landscape, FDORA is still in force, and FDA is expected to follow through with the mandate to issue and finalize guidance that addresses the following: (1) the format and content of the DAPs, (2) submission of any modifications to the DAP, (3) considerations for public posting of key information about the DAP, (4) waiver criteria, and (5) how sponsors will provide progress updates on meeting or not meeting enrollment goals.

In the meantime, companies may continue to anchor their clinical trial design and patient recruitment efforts in science, epidemiology, and medical assessments. By doing so, they may be better prepared for various outcomes related to the DAP requirements. 

When considering the demographics of clinical trial enrollment, companies may consider, for example:

• Differential responses to treatment due to genetics, health literacy, comorbid conditions, hormonal factors, lifestyle, and environment
  
  
• Variations in drug metabolism and side effects among distinct groups
  
  
• Unmet needs in clinical trials that may address differences in health outcomes
  
  
• The need to evaluate how different populations respond to treatment, and
  
  
• Disease incidence, which may have a disproportionate effect on certain demographic groups.

For more information

DLA Piper is monitoring these developments and will continue to provide updates on this topic as it evolves. For more information, please contact the authors. 

_{[1] Thompson Schick, Axelsen, “Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Pivotal Clinical Trials for Drug Approvals,” FDLI 2022, https://www.fdli.org/wp-content/uploads/2024/09/FDLJ-77-2-Schick-and-Axelsen.pdf}

_{[2] Harris E., “FDA Proposes Guidance for Increasing Diversity in Clinical Trials,” JAMA, 2024;332(7):524. doi:10.1001/jama.2024.13388}