FDA Drafts Guidance Document to Assist Sponsors with Diversity Action Plans

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FDA issued a draft guidance on June 26, 2024 with the purpose of helping medical product sponsors submit Diversity Action Plans to support select clinical studies (1). The document, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, available on the FDA’s website, will be open for comments through September 2024 (2).

Sponsors are now required to submit Diversity Action Plans following the Food and Drug Omnibus Reform Act (FDORA) adding new provisions to the Federal Food, Drug and Cosmetic Act (1). Diversity Action Plans, according to an FDA press release, “must specify the sponsor’s rationale and goals for clinical study enrollment,” and how the sponsor will meet those goals, governed by the age group, ethnicity, race, and sex of any populations that are clinically relevant.

“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,” Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence (OCE) and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research (CDER), said in the release (1). “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.”

OCE and CDER were two of the issuing offices on the draft guidance, along with FDA’s Centers for Biologics Evaluation and Research, and Devices and Radiological Health; and the Offices of the Commissioners of both the Office of Minority Health and Health Equity, and the Office of Women’s Health (2).

In a general sense, the press release said, Diversity Action Plans are meant to facilitate better understanding of a disease or medical product that is being studied, while more broadly applying the results of clinical studies across different patient populations.

“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, MD, in the release (1). “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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 response to the draft guidance being released, Jeff Allen, PhD, president and CEO of Friends of Cancer Research, commented after attending a meeting on the topic at the White House.

“While FDA has long been committed to improving diversity in clinical trials, this new guidance which was required by Congress through the DEPICT [Diverse and Equitable Participation in Clinical Trials] Act that was included in FDORA, will provide a framework for Diversity Action Plans,” Allen said (3). “Implementing these plans can play a major step forward to make clinical trials more inclusive of patient populations frequently underrepresented and ensure that pivotal trials are representative of the people that will ultimately receive new therapies.”

References

1. FDA. FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies. Press Release. June 26, 2024.
2. FDA. Draft Guidance for Industry, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (OCE, June 2024).
3. Comment received via email correspondence on June 26, 2024.