FDA Diversity Action Plan in 2026: Is a Diversity Action Plan Still Required for Clinical Trials?

The Diversity Action Plan requirement has been the most talked-about, least enforced piece of United States clinical research policy in recent years. Congress passed it, the Food and Drug Administration drafted guidance for it, and sponsors voluntarily submitted hundreds of plans in preparation. Then, over 2025 and into 2026, the guidance stalled, restarted under court order, missed its statutory deadline, and was effectively replaced by a different final guidance that removed the word diversity from the title. For sponsors planning pivotal trials, the practical question is what to do in the meantime.

This article covers the current status of the Diversity Action Plan requirement, the difference between the statute and the guidance, what sponsors are doing during the pause, and how to build representative enrollment into study design in a way that survives whichever direction United States policy moves next.

What is a Diversity Action Plan and where did it come from?

A Diversity Action Plan, often shortened to DAP, is a document a sponsor submits to the FDA that lays out enrollment goals for a clinical trial, broken down by race, ethnicity, sex, and age group. The plan explains why those goals make sense based on how the disease affects different populations in the United States, and how the sponsor will actually reach them through site selection, community outreach, and recruitment strategy.

The requirement traces back to the Food and Drug Omnibus Reform Act, known as FDORA, signed into law in December 2022. FDORA instructed the FDA to require DAPs for certain pivotal studies, covering Phase 3 studies of new drugs and pivotal studies of certain medical devices, and directed the FDA to issue guidance on what these plans should contain.

The scientific concern is straightforward. Clinical trials have historically enrolled a narrower slice of the population than the patients who ultimately take the approved drug. When enrollment does not reflect the treated population, questions about safety and effectiveness in underrepresented groups often surface only after approval. FDORA was Congress's attempt to require sponsors to plan for representative enrollment up front.

Why is the Diversity Action Plan requirement in limbo right now?

The FDA published draft DAP guidance in June 2024, roughly a year and a half past the deadline Congress had set. The public comment period closed in September 2024, and the statute expected finalization within nine months, pointing to a target of about June 2025.

The policy environment then changed. In January 2025, following executive orders directing federal agencies to unwind diversity, equity, and inclusion programs, the draft DAP guidance was removed from the FDA website. It was restored the following month under court order with a disclaimer from the Department of Health and Human Services. The June 2025 statutory deadline came and went without a final guidance.

In December 2025, the FDA finalized a different document titled Enhancing Participation in Clinical Trials, which addresses eligibility criteria, enrollment practices, and trial designs. The word diversity does not appear in the title. It urges sponsors to enroll participants who reflect the intended-use population by age, sex, race, ethnicity, and factors such as comorbidities and organ function, but does not create a mandate to submit a DAP. Legal analysts have described the older draft DAP documents as effectively obsolete under this new final guidance.

For a companion perspective on how the same debate is playing out in patient communities, see the Diversity Action Plan debate explained for advocacy groups, which covers how patient and advocacy organizations are interpreting the same pause.

Statute versus guidance: what does the pause actually mean for sponsors?

This is the most important distinction for anyone planning a pivotal study right now. FDORA is still law. Congress has not repealed it. The sections it added to the Federal Food, Drug, and Cosmetic Act remain on the books. What is missing is the mechanism that would activate the requirement for sponsors.

Under the statute, the DAP mandate switches on 180 days after the FDA publishes a final guidance on the form and content of DAPs. Because no final DAP guidance exists, that 180-day clock has never started. A sponsor cannot be penalized for not submitting a DAP today, because there is no active regulatory requirement to submit one. Once the mandate activates, failure to submit would be a prohibited act under the Federal Food, Drug, and Cosmetic Act, but that exposure only exists once the requirement is in force.

The situation is a pause, not a repeal. The statutory expectation that pivotal trials be representative has not disappeared. It has simply lost the enforcement vehicle Congress attached to it. A future administration or a finalized guidance could reactivate it, and a July 2026 push from some lawmakers has already asked the FDA to implement the law, reframing it in terms of scientific representativeness.

What are sponsors actually doing during the pause?

Most sponsors have kept the work moving. Before any mandate was in force, sponsors voluntarily submitted several hundred diversity plans across the FDA's drug, biologic, and device centers during fiscal years 2023 and 2024. Several large pharmaceutical companies confirmed in early 2025 that their work on trial representativeness remains ongoing and is treated as a core part of study design.

Some companies have quietly changed how they talk about the work. Public reporting has become more clinical and less political, and some investigator and demographic metrics that were previously reported externally have moved to internal tracking. The activity continues. The language surrounding it has become more careful.

For a practical playbook on keeping representative enrollment moving without slowing recruitment timelines, see how sponsors build a diverse enrollment pipeline without slowing the study.

A recent industry survey found that only about a quarter of clinical trial professionals said their organizations currently benchmark disease demographics against enrolled populations. Sponsors who are ahead on this work are ahead because they are measuring, not because they are talking about it.

Why representative enrollment still matters regardless of United States policy

Even if the DAP requirement never activates in its current form, three forces keep the underlying question alive for sponsors.

Drug behavior varies across populations

Pharmacokinetics, which is how a drug moves through the body, and pharmacodynamics, which is what the drug does in the body, differ meaningfully across ancestry and sex. Enzymes that metabolize drugs vary in activity across genetic populations, and sex-based differences alter clearance for many common medications. When a trial does not include the full population that will take the drug, the safety and dosing profile in unstudied groups has to be inferred rather than measured.

Global regulators are moving toward representativeness, not away from it

The European Medicines Agency, or EMA, relies on International Council for Harmonisation, known as ICH, guidelines that address ethnic factors and multi-regional trials. ICH E17 and ICH E8(R1) both push sponsors toward representative enrollment. Ignoring representativeness in a United States pivotal study can create friction in the same molecule's European or global submissions.

The related quality expectations under the newest Good Clinical Practice standard are covered in what ICH E6(R3) means for sponsors: quality by design from day one, which is worth reading alongside any DAP planning.

Payers, health technology assessors, and labels reward representative data

Health technology assessment agencies and reimbursement decision-makers increasingly ask for evidence that reflects the population that will actually receive the therapy. Thin subgroup data invites reimbursement delays and narrower label language. This is a commercial argument, not a policy argument.

What should sponsors do right now, in practical terms?

The most defensible posture during the pause is to keep doing the work, document it in enrollment and statistical terms, and stay ready to submit a formal DAP quickly if the mandate activates.

Build representativeness into protocol design at the feasibility stage

Set enrollment targets that reflect the epidemiology of the condition in the United States before enrollment opens. Reconsider overly narrow Phase 2 exclusion criteria that make representative Phase 3 enrollment structurally impossible. This is easier to fix at the protocol stage than with recruitment tactics later.

Select sites for demonstrated access to the target population

Site selection is where enrollment planning either delivers or fails. Sponsors who select sites based on documented ability to reach the intended-use population, rather than prior throughput alone, hit representative enrollment goals more consistently.

For an operational view of how demographic tracking works across sites at scale, see cross-site enrollment demographics and how CROs harmonize, aggregate, and report.

Use hybrid and decentralized elements to reduce participant burden

Long travel, frequent visits, and rigid clinic hours filter out the same populations trial after trial. Telehealth check-ins, local laboratory partnerships, in-home nursing, and flexible visit windows expand reach without changing the science.

Document everything in neutral, scientific language

Maintain an internal document that functions as a DAP by another name. Anchor the language in enrollment epidemiology and statistical rationale, not policy vocabulary. This keeps the work defensible during the pause and submission-ready if the requirement activates.

Choose recruitment partners who can measure and course-correct

The industry benchmarking gap is real. Sponsors who work with recruitment and pre-screening partners that can compare enrolled demographics against the target population in real time can adjust site allocation and outreach while the study is still open, rather than discovering the gap in the final analysis.

For the sponsor-facing evaluation criteria that matter here, see choosing the right patient recruitment partner for your clinical trial.

How DecenTrialz supports sponsors during regulatory uncertainty

DecenTrialz is a United States-based clinical trial recruitment and pre-screening platform that combines AI-assisted participant matching with registered nurse-led pre-screening to connect potential participants with research sites, and gives sponsors real-time visibility into recruitment funnels and enrolled demographics across sites. The research site owns final eligibility determination, informed consent, study walk-through, and enrollment. Sponsors can use this visibility to benchmark and adjust representative enrollment while the study is open.

Frequently asked questions about Diversity Action Plans for sponsors

Is the Diversity Action Plan requirement still law?

Yes. The statutory requirement created by FDORA in December 2022 remains on the books. What is missing is a final FDA guidance, which is the mechanism that activates the requirement for sponsors.

Can the FDA penalize a sponsor for not submitting a DAP today?

No. Because the requirement has not activated, there is no current enforcement basis for penalties tied to DAP submission. That could change if a final guidance is issued.

Should sponsors still submit voluntary diversity plans?

Many sponsors continue to do so, particularly for pivotal studies where representative enrollment is expected by global regulators, payers, and the FDA's December 2025 final guidance on Enhancing Participation in Clinical Trials. The decision is now strategic rather than compliance-driven.

Does the European Medicines Agency require something similar?

The EMA does not use the DAP framework, but ICH guidelines that the EMA follows, particularly ICH E17 and ICH E8(R1), push sponsors toward representative enrollment. Global development programs still need to plan for this.

What happens if the FDA finalizes DAP guidance later?

The 180-day clock in FDORA would start. Studies that begin enrollment after the compliance date would need to submit a DAP with the relevant application. Sponsors who have maintained an internal DAP-equivalent document would be positioned to submit quickly.

Where the Diversity Action Plan question goes from here

The Diversity Action Plan requirement is paused, not gone. The scientific and commercial reasons for representative enrollment are unchanged, global regulators are moving in the same direction, and Congress has not repealed the statute. A future administration or a finalized guidance could restart the clock quickly. Sponsors who have kept representativeness embedded in protocol design, site selection, and demographic measurement will not need to change course when that happens. Sponsors who paused the underlying work along with the policy will.

The most useful posture right now is quiet continuity. Do the work. Measure it. Document it in the language of enrollment epidemiology and statistical rationale. Regulatory uncertainty is temporary.