Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)).

FDA’s recent publication of the draft guidance document on Diversity Action Plans (Draft Guidance) addresses Congress’s requirement for FDA to publish guidance describing Diversity Action Plan development, content, submission, and waiver practices. This guidance, when finalized, will begin the countdown to these requirements coming into effect for clinical trial sponsors, as the requirements of FDORA Section 3601 apply to clinical trials where “enrollment commences” 180 days after FDA’s finalization of the Draft Guidance.

Content

Applicable to phase 3 or pivotal clinical studies of drugs and biologics and many clinical trials of medical devices, the Draft Guidance describes the content of Diversity Action Plans, including enrollment goals (disaggregated by race, ethnicity, sex, and relevant age group, informed by the applicable condition or disease and the intended population studied in the clinical trial), sponsor rationales and methodologies used to arrive at the enrollment goals, and information on measures to meet the enrollment goals. According to the Draft Guidance, FDA generally expects that Diversity Action Plans will not typically exceed 10 pages in length.

Timelines

The Draft Guidance provides that Diversity Action Plans must be submitted to FDA for drugs and biologics no later than the date of submission of the protocol to the Investigational New Drug (IND) application for the applicable clinical study. FDA, however, recommends sponsors submit their Diversity Action Plans earlier, in connection with a meeting request to discuss the applicable clinical study (such as an End-Of-Phase-2 meeting).

Similarly, for medical devices, the Draft Guidance provides that sponsors must submit a Diversity Action Plan as part of an Investigational Device Exemption (IDE) application, when the device clinical study requires an IDE application. A sponsor may also seek FDA’s feedback on its Diversity Action Plan through FDA’s Q-submission process.

Waivers

Section 3601 provides FDA with authority to waive a sponsor’s obligation to submit a Diversity Action Plan. The Draft Guidance, however, emphasizes that waiver considerations will be made on a case-by-case basis and, in part because FDA believes that Diversity Action Plans will be feasible in most cases, will likely be granted infrequently. The Draft Guidance provides that waivers may be granted in three instances: (1) when it would be necessary “based on what is known or what can be determined about the prevalence or incidence in the U.S. of the disease or condition;” (2) when conducting the trial in accordance with a Diversity Action Plan would otherwise be “impracticable;” and (3) when a waiver would be necessary to protect the public health during a public health emergency. Potentially seeking to discourage waiver requests, the Draft Guidance notes that information regarding waivers may be published publicly by FDA.

Disclosure

In the Draft Guidance, FDA strongly encourages sponsors to publicly share their strategies for meeting Diversity Action Plan enrollment goals and measures taken to achieve these goals. Coupled with FDA’s position on potentially posting waiver information publicly, this recommendation suggests that FDA may rely on transparency measures in support of (or in lieu of) direct enforcement mechanisms to drive compliance with these new requirements.

Key Recommendations

• Interested parties should submit comments to the FDA docket regarding the Draft Guidance. The public comment period will remain open until September 25, 2024. Comments may be submitted to Docket No. FDA-2021-D-0789. Section 3601 requires that FDA finalize the Draft Guidance within 90 days of its publication in draft form, which would follow fairly shortly after the close of the comment period.
• Sponsors of applicable clinical trials that are slated to begin enrollment in 2025 and thereafter should watch closely for finalization of the Draft Guidance beginning in late 2024. Relatedly, sponsors should begin planning for the development of Diversity Action Plans alongside the development of other clinical trial requirements to ensure that these new requirements will be met when they go into effect.