FDA Draft Guidance on Improving Underrepresented Population Enrollment in Clinical Studies

The U.S. Food and Drug Administration (FDA) recently issued “Diversity Action Plans to Improved Enrollment of Participants from Underrepresented Populations in Clinical Studies.”  This draft guidance “describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan.”  Including diverse participants in clinical studies is recognized to facilitate broader applicability of study results as well as enhance understanding of the medical product and disease being studies.  Diversity Action Plans for specific clinical studies became required with 2022 updates to the Food, Drug and Cosmetic Act. [See Pub. L. No. 117-328, div. FF, title III, §§3601(a), 3602 Dec. 29, 2022; codified at 21 U.S.C. 355 (z).]   In the FDA’s new draft guidance, clinical study sponsors and investigators are urged “to consider the many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race to enroll populations that represent the patients who will be treated if the product is approved.”  Comments on the draft guidance should be submitted by 9/26/2024.  For additional information, see 89 Fed. Reg. 54,010 (June 28, 2024).