How FDA's Diversity Action Plan Requirement Is Changing Clinical Trial Regulatory Work

Introduction

Clinical trial diversity has been a stated FDA priority for years, expressed mostly through draft guidance documents, public recommendations, and steady pressure on sponsors to enroll patient populations that look more like the people who actually have the disease being studied. The Food and Drug Omnibus Reform Act of 2022, commonly referred to as FDORA, changed the nature of that expectation by writing a specific, documented requirement into law: sponsors of certain clinical investigations must submit a Diversity Action Plan describing how they intend to enroll a patient population that reflects the condition's real-world demographics. For regulatory affairs teams, this moves diversity planning out of the realm of good practice and aspiration and into the realm of a submission requirement that can genuinely affect a program's timeline if it is handled as an afterthought rather than built into the regulatory strategy from the start.

Understanding what a Diversity Action Plan requires, when it is required, and how it fits into the broader submission package is now a practical, day-to-day skill for anyone working on clinical regulatory strategy, not simply a policy talking point to mention in a conference presentation. It is also one of the clearer examples in recent years of Congress, rather than the agency itself, directly shaping a specific piece of the clinical submission package, which is worth noting for anyone trying to anticipate where future regulatory requirements are likely to originate.

What FDORA Actually Requires

FDORA directs FDA to require a Diversity Action Plan for certain phase 3 studies, or other pivotal studies, of a drug or device, submitted early enough in development that it can genuinely inform the trial's enrollment strategy rather than simply documenting results after enrollment has already closed. The plan has to lay out enrollment goals for demographic subgroups relevant to the disease or condition under study, broken out by factors such as age, sex, race, and ethnicity, along with a clear rationale for those goals grounded in the actual epidemiology of the condition rather than a generic or aspirational target copied from another program.

It also has to describe the specific operational steps the sponsor will take to meet those goals, covering things like site selection criteria, community engagement plans, language accessibility, and protocol design choices that affect who can realistically participate, such as visit frequency, travel burden, or eligibility criteria that may inadvertently exclude the very populations the plan is meant to include. FDA has the authority to grant waivers in specific circumstances, such as when diversity enrollment goals are not practicable given the rarity of a condition or other legitimate scientific or logistical constraints, but a waiver request itself still has to be submitted and justified in writing, which means a sponsor still has to engage seriously with the underlying analysis rather than simply opting out of the conversation. The requirement applies going forward from its effective date and is layered onto existing IND and submission processes rather than replacing them, which means regulatory teams have to fit a new deliverable into an already familiar workflow rather than learning an entirely separate process.

What This Changes in Practice

The most immediate shift is timing. A Diversity Action Plan has to reflect genuine, actionable enrollment strategy, which means it needs real input from clinical operations, site feasibility, and often medical affairs well before a protocol is finalized, not retrofitted after sites are already selected and contracts are already signed. Regulatory affairs is typically the function responsible for assembling the plan into submission-ready form and tracking it through FDA's review and any subsequent requests for clarification, which puts regulatory in the position of pulling epidemiological and operational input from multiple functions on a timeline that is now tied to a legal requirement rather than a loosely enforced best-practice recommendation that could slip without immediate consequence.

It also changes how regulatory teams interact with epidemiology and biostatistics on a routine basis rather than only at major program milestones. Setting a credible, well-justified enrollment goal requires real disease prevalence data broken down by the relevant subgroups, and FDA reviewers are positioned to push back on goals that look arbitrary, rounded for convenience, or disconnected from the condition's actual population. Sponsors who have historically treated diversity enrollment as a secondary consideration, something handled informally by clinical operations without much regulatory visibility, are finding they need a more rigorous, earlier conversation with their epidemiology function to produce a plan that will actually survive agency review rather than generate a round of follow-up questions.

There is also a documentation burden that did not exist in the same form before this requirement took effect. A Diversity Action Plan is reviewed, can generate FDA feedback or a formal information request, and becomes part of the permanent regulatory record for the program going forward. That means it needs the same level of internal review, version control, and sign-off rigor as any other submission component, including clear ownership of updates if enrollment realities shift partway through the trial, and regulatory affairs professionals are typically the ones building that process where it does not already exist within a given organization.

How This Compares to What Came Before

Sponsors are not starting from zero. FDA had already published draft guidance encouraging diversity plans for clinical trials for several years before FDORA, and many larger sponsors had voluntarily adopted some version of a diversity enrollment strategy as a matter of internal policy or investor expectation. What FDORA changes is the enforceability and the specificity. A voluntary plan that an internal team quietly deprioritized when enrollment got difficult is a very different thing from a statutory submission requirement tied to a pivotal trial, one that a reviewer can comment on, request revisions to, and reference in subsequent correspondence about the program. Sponsors who treated earlier diversity guidance as a reputational nice-to-have now have to treat the equivalent analysis as a gating submission component, which is a meaningful shift in how seriously the underlying work gets resourced internally.

This also changes the conversation sponsors have with contract research organizations and site networks. A CRO that has historically treated site selection as primarily a matter of enrollment speed and cost now has to factor demographic reach into its proposal, since the sponsor's Diversity Action Plan commitments depend on the CRO's actual site footprint being able to deliver the population the plan describes. Sponsors that have not already asked their CRO partners pointed questions about site demographic reach are likely to find that conversation overdue once a Diversity Action Plan is due.

What Regulatory Professionals Should Be Building Now

For regulatory affairs professionals working on pivotal trials, a few habits are worth building early rather than waiting for the requirement to force the issue. Loop in clinical operations and biostatistics on enrollment diversity planning at the same point you loop them in on protocol design, not after a draft protocol already exists, since by that point many of the operational levers a plan might cite, like site selection or language accessibility, are already effectively locked in and expensive to change. Keep a working familiarity with the epidemiology of the indications your pipeline touches, since a credible Diversity Action Plan goal has to be grounded in real prevalence data rather than a generic enrollment target borrowed from a comparable but not identical program.

Track FDA's evolving guidance on this requirement closely as well, since the statute sets the broad framework but the agency's implementing guidance is where the practical expectations, templates, and review standards actually get filled in, and that guidance is likely to be refined further as the agency gains experience reviewing a larger volume of actual plans across different therapeutic areas. It is also worth building a standard internal template and review checklist now, even an imperfect one, rather than treating each Diversity Action Plan as a one-off exercise, since programs with multiple pivotal trials will otherwise end up reinventing the same analysis repeatedly instead of refining a shared, improving process over successive submissions.

It is worth building a working relationship with whoever handles site contracting and CRO oversight as well, even if that function does not formally report through regulatory affairs. A Diversity Action Plan's credibility ultimately rests on whether the sites named in it can actually deliver the enrollment described, and regulatory professionals who stay disconnected from that operational reality risk submitting commitments the study cannot keep, which becomes its own problem well before the trial reaches its enrollment target.

Conclusion

The Diversity Action Plan requirement is a good example of how a policy priority becomes a concrete regulatory deliverable: what started as guidance, public commentary, and informal agency pressure is now a specific document, with a specific legal basis, that has to be prepared, justified, and defended through formal FDA review. For regulatory affairs professionals working on phase 3 or other pivotal studies, building fluency with this requirement, and the cross-functional coordination it demands from clinical operations, epidemiology, and biostatistics alike, is becoming a standard part of clinical regulatory strategy rather than a specialized add-on reserved for a handful of large sponsors.