Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance replaces the agency’s similarly-titled April 2022 draft guidance and has been issued to satisfy a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA) that the agency update or issue new draft guidance on the format and content of Diversity Action Plans. Under FDORA, Diversity Action Plans will be required for Phase 3 or other pivotal trials for drugs and for most device clinical trials, although some Diversity Action Plans for device trials can be first submitted with a marketing application such as a premarket notification where an investigational device exemption (IDE) is not required for the trial. The goal of Diversity Action Plans under FDA’s expanded authority is to increase enrollment and retention of clinically relevant study populations in clinical research, to help ensure adequate representativeness of study participants that reflect different age groups, sexes, and racial and ethnic demographic characteristics. Importantly, the FDA highlights that other factors may be important to consider in formulating a Diversity Action Plan, including geographic location, gender identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy status, lactation status, and co-morbidity. The FDA breaks down its Diversity Action Plan content expectations into three sections: enrollment goals, rationale for enrollment goals, and measures to meet enrollment goals.
FDA notes that, by statute, the requirements under FDORA for Diversity Action Plans apply to clinical studies with enrollment commencing after 180 days from publication of final guidance, which yesterday’s guidance is not, giving industry and stakeholders time to review and comment on the FDA’s draft guidance and to begin adapting to the direction the FDA is moving with this draft guidance. The FDA also carves out the following from needing a Diversity Action Plan: (1) clinical studies of drugs with protocols submitted within 180 days following the publication of the final guidance where enrollment is scheduled to begin 180 days after publication of the final guidance; (2) clinical studies of devices received by FDA in IDE applications within 180 days after publication of the final guidance; and (3) clinical studies of devices that do not require an IDE application to be submitted to FDA that are approved by an institutional review board (IRB) or independent ethics committee (IEC) within 180 days after the date of publication of the final guidance.
In setting enrollment goals, FDA points out that sponsors should take into account the overall clinical development strategy—i.e., if there are multiple clinical studies that would be subject to Diversity Action Plan requirements, the sponsor should work towards “overall proportionate representation,” even if an individual study does not have proportionate representation. However, we note that while FDA acknowledges that rare disease development programs may include a single, small pivotal study that may preclude detection of any differences in safety or effectiveness across the study population, the draft guidance does not exempt rare disease programs from Diversity Action Plan requirements.
Overall, the draft guidance is far more detailed than the agency’s prior, pre-FDORA draft guidance, and FDA includes an Appendix summarizing the required elements of a Diversity Action Plan with a proposed layout sponsors can employ in preparing these submissions, noting that the plan itself should be “succinct” (i.e., generally not exceeding 10 pages, excluding references, in most cases).
Finally, the draft guidance specifies timelines for submitting these plans and procedures for receiving feedback from the FDA. Additionally, the document discusses waivers for these plans and encourages sponsors to consider publicly posting key information from their plans to promote transparency. The draft guidance is set to publish in the Federal Register tomorrow and will be open for 90 days for public comments.
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