FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

An analysis from the Life Sciences legal team at Hogan Lovells.

From our publishing partner:


Hogan Lovells Engage

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which outlines the medical products and clinical studies for which a Diversity Action Plan (DAP) is required, the format and content of DAPs, and the process for submitting DAPs to FDA. It also outlines the criteria and process FDA plans to use to evaluate a sponsor’s request for a waiver. FDA invites comments on the draft guidance through September 26.

The draft guidance states that compliance with the DAP initiative will not come into effect until 180 days after the future final guidance is published. Even so, sponsors should start planning how they will comply with these significant new requirements.


The Food and Drug Omnibus Reform Act of 2022 (FDORA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require drug and device sponsors to submit diversity action plans (DAPs) for the stated purpose of increasing enrollment of subjects from historically underrepresented populations, which the agency believes will help the strength and generalizability of clinical evidence. FDORA’s DAP requirement reflected the principles outlined in FDA’s April 2022 draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” which we summarized online here. FDA has now issued draft guidance on DAPs which focuses on age group, sex, race, and ethnicity demographic characteristics of the clinically relevant study populations, including the rationale for the enrollment goal and an explanation of how the diversity goals will be attained. For purposes of the latest guidance, “underrepresented populations” in terms of race and ethnicity may include participants who are Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islander, and other persons of color. For sex and age, underrepresented populations may include female participants and participants in the older adult and pediatric age groups.

Despite the draft guidance’s focus on age, sex, and racial & ethnic diversity, FDA notes at the outset that “the broader issues regarding health disparities and differential access to health care and clinical studies that may occur based on other factors, including but not limited to geographic location, gender identity, sexual orientation, socioeconomic status (SES), physical and mental disabilities, pregnancy status, lactation status, and co-morbidity.” Accordingly, FDA encourages sponsors to consider such additional factors in their DAPs, “which may support subgroup analyses.” For example, a sponsor developing a DAP “should also consider the potential that pregnant or lactating individuals with the condition or disease may use the medical product,” the draft guidance advises.

It is important to note that, when finalized, this guidance will create binding requirements on study sponsors. This is unlike most FDA guidance documents that just provide the agency’s recommendations. As background, FDORA required the agency to specify the form and manner for the submission of DAPs in guidance; thus, specifications regarding the form and manner for the submission of a DAP as described in the final guidance will have a binding effect.

Below we have summarized the draft guidance’s recommendations and requirements as they pertain to:

  • which drug and device sponsors should submit DAPs;
  • the types of content that should be included in a DAP, including the enrollment goals, the rationale for those goals, and metrics to meet them;
  • the timeline and procedures for submission of a DAP to FDA;
  • how diversity goals should be considered when conducting multinational studies; and,
  • the circumstances under which FDA may grant a waiver for a DAP.

Continue reading the original Hogan Lovells Engage blog post with additional insights including:

  • Which clinical trials require DAPs?
  • Enrollment goals
  • Rationale for enrollment goals
  • Measures to meet enrollment goals
  • Timeline & procedure for submitting DAPs to FDA
  • Waivers
  • Enforcement and post-marketing requirements
  • Next steps

Read more…

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