FDA Issues Draft Guidance on the Submission of Diversity Action Plans

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The FDA has issued a draft guidance which provides details to medical product sponsors on submitting Diversity Actions Plans to support clinical studies. The guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” describes the format and content required as well as the timing and process for submitting Diversity Actions Plans to the FDA.¹

According to the FDA, Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.

“Participants in clinical trials should be representative of the patients who will use the medical products,” FDA Commissioner Robert M. Califf, MD, said in a press release. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

In addition to the format, content, timing, and process required for submitting Diversity Actions plans, the draft guidance outlines the FDA’s own process by which the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, or a waiver.

When submitted, Diversity Action Plans must specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age group, ethnicity, sex and race of clinically relevant study populations) and describe how the sponsor intends to meet those goals. The guidance also urges sponsors and investigators to consider all facets of clinical trial diversity—even those that go beyond ethnicity, sex, and race.

Under the Federal Food, Drug, and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA), sponsors are now required to submit Diversity Actions Plans. The plans apply to Phase III clinical studies and/or other studies deemed to be pivotal, including certain studies of medical devices. The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guidance.

The draft guidance was developed by the Oncology Center of Excellence Project Equity in collaboration with the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity.

“Generating data for a broader and more representative population early in the clinical development program is among the FDA’s priorities to bring innovative medical products to the public. With FDORA, there is now a requirement for sponsors to submit diversity action plans. These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research said in the press release.

Reference

1. FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies. FDA. News release. June 26, 2024. Accessed June 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies