by: TigerPosted on:

REVERSAL – The FDA will be mandating DEI for ortho clinical studies.

UPDATE – After Trump Executive Orders, FDA Removes Diversity Guidance From Website

Days after President Trump issued an executive order (EO) taking aim at diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, previously issued draft guidance on diversity in clinical trials was removed from the website of the U.S. Food and Drug Administration (FDA). While the removed guidance was in draft form, it is highly unusual for FDA to revoke or alter draft guidance without issuing a statement or further guidance. This move raises questions about the applicability of statutory obligations to submit clinical trial Diversity Action Plans and the agency’s current thinking on best practices for clinical development.

Executive Orders

Late on January 21, 2025, President Trump issued an EO requiring federal agencies to terminate all “discriminatory and illegal . . . policies, programs, activities, guidance, regulations, enforcement actions, consent orders and requirements” relating to DEI. The EO also rescinded several prior executive orders on diversity in place since 1965 and ordered the Office of Management and Budget to “review and revise, as appropriate, all Government-wide processes, directives, and guidance”. This followed an EO issued on January 20, the first day of President Trump’s second term, which states the policy of the United States is to only recognize two sexes, including a definition of “sex” that excludes “gender identity” and defines “sex” as an individual’s immutable biological classification as either male or female.” A separate EO required agencies to temporarily pause issuing new regulations and recommended that agencies reopen comment periods on published rules. However, removing the draft guidance here appears to be unrelated to that EO, as FDA has not gone so far as to remove other draft guidance unrelated to diversity, equity, inclusion, gender, or sex.  So far, no Trump Administration EO has made specific mention of FDA or its guidance for industry.

Guidance Removed

On January 23, public reports noted that previously issued draft guidance on Diversity Action Plans and considerations for evaluating sex- and gender-specific data in medical device clinical trials were removed from the FDA website.

  • Diversity Action Plans: The Food and Drug Omnibus Reform Act (FDORA), signed into law by President Biden in 2022, requires drug and device sponsors to submit clinical trial Diversity Action Plans to FDA ahead of pivotal clinical studies, including the sponsor’s goals for enrollment in the trial, the rationale for these goals, and an explanation for how the sponsor intends to meet those goals. Such goals must be disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations. FDORA also required FDA to issue guidance outlining the form and content of Diversity Action Plan submissions sponsors must follow and provide recommendations for sponsors on other aspects of the plans. FDA issued draft guidance required by FDORA in June 2024 and is required by FDORA to issue final guidance no later than nine months after closing the comment period on such draft guidance, which ended on September 26, 2024. Further Crowell analysis of Diversity Action Plans and the draft guidance is available here.
  • Evaluation of Sex- and Gender-Specific Data in Clinical Studies: On January 7, FDA issued draft guidance recommending that sponsors investigate whether sex- and/or gender-specific differences exist for the intended effect of the device. Before it was removed from the FDA website, the guidance provided recommendations for trial design, statistical analysis and enrollment. These recommendations are intended to improve knowledge and information relating to the condition/disease a medical product is intended to cure, treat, diagnose, mitigate, or prevent in the following areas:
    • sex- and/or gender-specific prevalence;
    • sex- and/or gender-specific diagnosis and treatment patterns;
    • limited clinical evidence due to a disproportionately low number of females/women enrolled in prior studies;
    • identification of any known clinically meaningful sex- and/or gender-specific treatment effects; and
    • differences in outcomes related to either safety or effectiveness.
    For purposes of the draft guidance, “sex” is a “biological construct based on anatomical, physiological, hormonal, and genetic (chromosomal) traits” and “gender” is “a multidimensional construct that encompasses how an individual self-identifies.” The draft guidance included specific recommendations related to study design, enrollment and retention of study participants, data collection and analysis, interpretation of clinical study results, and analysis of outcomes in clinical studies.Unlike the Diversity Action Plan guidance, this guidance was not mandated by statute, and this draft guidance does not confer any legal responsibilities on sponsors. However, FDA noted in the draft Diversity Action Plan guidance that sex and gender are important considerations in medical device development and performance, including recognizing that there are clinically meaningful differences associated with sex (including body size, pregnancy state, and hormonal changes) and differences associated with gender (including pain assessment and management, clinical outcomes, and health care utilization). Because there has been underrepresentation of females/women, intersex individuals, and those with differences in sex development in medical device clinical trials, the guidance aimed to improve the generalizability of research results by providing considerations and recommendations to ensure appropriate representation of individuals of different sexes and genders.

In June, the FDA released a draft guidance aimed at enhancing diversity in clinical trials by encouraging companies to develop Diversity Action Plans. These plans are intended to increase participation from underrepresented populations, addressing factors like race, ethnicity, sex, and age in drug and device trials. As part of their Investigational Device Exemption (IDE) applications, companies will now need to outline enrollment goals for these demographics and strategies to achieve them.

While this guidance is not yet fully implemented, FDA’s Center for Devices and Radiological Health (CDRH) representative, Dr. Tarver, stressed that now is the time to begin formulating diversity plans. He advised companies to seek feedback early, to gain a clearer understanding of what their diversity plans should look like.

According to Tarver, the FDA has already received a significant number of these diversity action plans, signaling early engagement from industry stakeholders.

Tarver also underscored the role of patient feedback in the trial process, referencing the FDA’s 2022 final guidance on patient engagement. This focus on patient input has already led to modifications in clinical trials and improved communication strategies to increase participation.

Ultimately, Tarver urged companies to think about ways to improve patient adherence and participation in trials. He emphasized the need for diversity plans to support inclusion without creating additional barriers for underrepresented groups. The underlying goal is to ensure that these efforts enhance rather than complicate clinical trial participation.

So, is the FDA really pushing for DEI in clinical studies?

The answer appears to be a resounding yes, with concrete steps being taken to integrate diversity and patient-centered approaches into the heart of clinical trial design.