Diversity Action Plans: What sponsors need to know about the latest FDA guidance

By Beatriz Rocha, MD, PhD, Chief Regulatory Liaison Officer

The FDA’s much-anticipated Diversity Action Plan guidance was published on June 26th, 2024. This is still a draft guidance with a comment period of 90 days; Fortrea’s Diversity Workstream group will be working with Fortrea’s Regulatory Intelligence team to compile comments and submit them to the FDA.

Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), legislation requires Diversity Action Plans (DAPs) to be submitted to Phase III/pivotal clinical studies for which enrollment commences 180 days from the publication of the final guidance. As this is not yet the final guidance it did not trigger the 180-day timeline. However, a final guidance might be expected sooner than later after the 90-day public comments period.

What remains the same

The two draft guidance documents (the June 2024 draft replaces the April 2022 draft) are both aligned in promoting an increase in enrollment of participants who are members of historically underrepresented populations in clinical studies (including clinical studies for medical devices) to help improve the strength and generalizability of the evidence for the intended use population.

Additional factors included

The latest guidance considers factors beyond what is required by FDORA (age, sex, racial and ethnic demographic characteristics) when developing enrollment goals—including geographic location, gender identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy or lactation status, and comorbidities.

It also specifically indicates that global clinical development programs should reflect enrollment goals for the entire study population and not be limited to US-enrolled participants and that a proportional representation is not needed in every clinical study, but such representation should be achieved in the totality of the clinical development program.

Understanding recommendations versus requirements

Interestingly, while in general FDA’s guidance documents do not establish legally enforceable responsibilities and are seen as recommendations as per the use of the word should, an exception to this framework derives from the requirement in section 3601 of FDORA for FDA to specify in guidance, the form and manner for the submission of the DAPs it will have binding effect, once this guidance is finalized, as indicated by the use of words must, shall or required (see section VII of the guidance).

Proactively anticipating changing regulations

The Fortrea Regulatory Strategy Consulting team continues to closely track the US regulatory landscape to meaningfully improve the diversity of clinical trial participants. Learn how we draw on our experience working on 37 Diversity Action Plans to date to help sponsors meet legal requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.

Learn more about our solutions to support Diversity Action Plans.