The Diversity Action Plan debate, explained for advocacy groups

A federal rule that was supposed to make clinical trials more representative of the people who will one day take approved medicines has spent the last two years moving in and out of view. Sponsors have watched it get published, pulled, restored, and left unfinished. Communities have watched the headlines and drawn their own conclusions about whether the research system still intends to include them.

For advocacy groups, the noise around Diversity Action Plans (DAPs, the formal enrollment plans certain trial sponsors must file with the U.S. Food and Drug Administration) has created a real problem. It is harder to answer basic community questions when the rules keep shifting. This article walks through where the requirement came from, what has actually changed, and what advocacy groups can do while the policy sits in an unfinished state.

Why Diversity Action Plans exist in the first place

For decades, the people enrolled in clinical trials have not reflected the people who eventually use approved medicines. Black, Hispanic, Latino, Asian American, Native American, older adult, female, pregnant, and disabled participants have all been enrolled at rates below their share of the population most affected by the disease being studied.

The consequences show up later, in real clinical practice. When a therapy has been tested mostly in one narrow group, its performance in other groups is uncertain. Regulators sometimes have to add cautionary language to drug labels or require additional post-marketing studies to fill in the gaps. Access, safety information, and clinician confidence all suffer.

Congress addressed this pattern in December 2022 when it passed the Food and Drug Omnibus Reform Act (FDORA, a broad statute updating parts of the Federal Food, Drug, and Cosmetic Act). FDORA converted what had been a voluntary FDA recommendation into a statutory requirement: sponsors of certain pivotal trials would need to submit a Diversity Action Plan to the FDA. The law directed the agency to publish implementing guidance so that sponsors would know how to comply.

For a fuller picture of the underrepresentation problem and the community engagement work that has grown around it, see Maximizing Diversity: Engaging Underrepresented Communities.

What a Diversity Action Plan actually requires sponsors to do

A Diversity Action Plan is not a diversity statement. It is a concrete planning document that a sponsor files with the FDA before a covered trial begins.

Under the statute and the FDA draft guidance that followed, a DAP must contain three things. First, enrollment goals broken out by age group, sex, and racial and ethnic characteristics of the population that the medicine or device is intended to treat. Second, a rationale for those goals, grounded in what is known about who actually gets the disease and how severely. Third, the specific steps the sponsor plans to take to reach and keep those participants, including where trial sites will be located, how eligibility criteria will be reviewed, and what support (such as travel help or flexible visit options) will be offered.

The requirement applies to pivotal drug and biologic trials (generally Phase 3, the large studies used to support approval) and to certain device studies. Early-phase and non-pivotal research fall outside the mandate, which is one of the ongoing criticisms of the framework: safety signals in underrepresented groups can appear well before Phase 3.

The draft guidance also strongly encouraged sponsors to make key parts of their plans publicly available, so that clinicians, patients, and advocacy partners could see the goals and hold sponsors accountable to them.

How the policy landscape shifted between 2024 and 2026

The FDA issued its revised draft guidance on Diversity Action Plans in June 2024. The public comment period closed in September 2024, which set an internal deadline for the agency to finalize the guidance by June 2025.

In January 2025, following executive orders from the U.S. government directing federal agencies to end diversity, equity, and inclusion programs, the DAP draft guidance was quietly removed from the FDA website along with several related documents. A federal court ruled in February 2025 that the removals were unlawful under standard administrative procedure, and the guidance was restored under court order, though with an administration disclaimer attached.

The June 2025 statutory deadline for finalizing the guidance came and went with no final version issued. As of mid-2026, the document remains a draft, marked as non-binding and not for implementation. The FDA has neither withdrawn it formally nor replaced it with something new.

In a parallel development that may matter more than the executive orders, House appropriators writing the FY2027 FDA funding bill in 2026 directed the agency to keep implementing the diversity-plan requirement for Phase 3 studies and to report on steps taken to reduce adverse drug events in women and minority populations. That direction came from the same governing coalition that had rolled back other diversity programs, which suggests the underlying scientific case for representative enrollment is holding up across party lines. Public visibility of the trial ecosystem, including where trials run and who is being included, is discussed further in Transparency in Clinical Research: Why Trial Information Access Matters.

Where things stand now and why the underlying law has not gone away

The most important thing to understand about the current situation is that the statutory requirement to submit a Diversity Action Plan is still on the books. Congress wrote it into law in 2022 and has not repealed it. What has not been settled is the implementing guidance, the FDA document that tells sponsors exactly how and when to comply.

Because that guidance is still a draft, the mandatory-submission clock has not started for many trials, and enforcement is uncertain in practice. But the legal obligation exists, and many sponsors continue to prepare DAPs voluntarily, both because their international regulators (in Europe, Canada, and other jurisdictions) expect representative enrollment, and because a therapy that is only tested in a narrow population is harder to sell, reimburse, and defend after approval.

In short: the mandate is intact, the operating instructions are unfinished, and voluntary practice is continuing in the meantime.

What the uncertainty means for the communities you serve

Regulatory uncertainty is not a neutral event. When the system that governs clinical research sends inconsistent signals about whether it intends to include certain communities, community members hear those signals clearly, and their willingness to engage with research changes accordingly.

Historically underrepresented communities were already navigating a long memory of research abuses, unequal healthcare access, and thin community ties to trial sites. A public back-and-forth about whether federal rules on diversity apply, do not apply, or apply in a softer way makes the on-the-ground work of building trust harder. It is easier for skeptics of research participation to argue that the promised protections are not real, and harder for community partners to answer confidently.

There is a downstream effect as well. When enrollment fails to reflect the population that actually has the disease, the data generated by the trial is a weaker guide to how the medicine will work in the community after approval. Communities that are underenrolled today receive less certain safety and effectiveness information in the future.

For a broader look at what representative enrollment looks like in practice across borders and populations, see Ensuring Equity: Strategies for Inclusive Global Clinical Trials.

Why representative enrollment is a scientific standard, not a political one

One of the most useful reframings that has come out of the last two years is the shift from framing representative enrollment as a DEI initiative to framing it as a drug-safety and generalizability standard. The scientific case is straightforward. A medicine tested in a narrow group produces data that generalizes narrowly. A medicine tested across the populations who will actually use it produces data that clinicians, payers, and patients can actually rely on.

That reframing matters for advocacy groups because it produces a message that holds up regardless of which administration is in power or which political framing is in fashion. Representative enrollment is about whether a medicine works, and works safely, in the people who will take it. It is a question of data quality, not political identity.

This framing is also the one now being adopted by congressional appropriators, sponsor scientific leadership, and international regulators. Advocacy groups that anchor their messaging in the scientific and safety rationale, rather than in the DEI language that has become contested, will find their arguments harder to dismiss. Technology partners are already building around this framing; a related discussion of how artificial intelligence is being used to support representative recruitment appears in AI in Clinical Trials: Driving Diversity and Inclusion.

How advocacy groups can hold the line while the guidance is in draft

The practical work does not need to wait for a final rule. Several actions that advocacy groups can lead or reinforce right now will keep representative enrollment moving forward regardless of how the policy resolves.

Continue investing in long-term community relationships. The organizations, clinicians, faith leaders, and community health workers who already have credibility in underrepresented communities are the infrastructure that recruitment depends on. Transactional outreach at the start of a trial rarely works if the relationships underneath it were not built years earlier.

Push sponsors to publish enrollment goals and progress voluntarily. The draft guidance encouraged public posting, and there is no reason sponsors cannot maintain that transparency practice on their own. Advocacy pressure to keep that norm alive is one of the strongest levers available.

Support plain-language education. Consent forms, eligibility descriptions, and trial information continue to be written at reading levels that exclude many potential participants. Translation, cultural adaptation, and readability improvements are low-cost, high-impact interventions that community organizations are often best placed to lead.

Track representativeness independently. When federal enforcement is uncertain, third-party tracking of who is being enrolled, in which trials, and against which disease-burden benchmarks becomes more valuable. Independent accountability builds durable pressure that does not depend on shifting agency priorities.

For a deeper look at how community-facing organizations sit at the center of modern recruitment models, see Why Patient Advocacy Groups Matter in Decentralized Clinical Research.

Where DecenTrialz fits in this landscape

DecenTrialz is a clinical trial recruitment and pre-screening platform that helps advocacy-referred community members connect with studies that may be a fit. Matching is supported by AI, and pre-screening is led by registered nurses (RNs, licensed clinicians trained in patient assessment and consent conversations).

DecenTrialz pre-screens only. The research site team handles final eligibility determination, informed consent, study walk-through, and enrollment. That scope boundary is important, especially for advocacy groups, because it means community members are handed off to the qualified clinical team at exactly the point where medical decisions begin.

For advocacy organizations, that division of labor removes friction. The community-facing work of trust, education, and referral is supported by a professional pre-screening layer, and the medical work stays with the site. Advocacy groups interested in a referral pathway for their communities can learn more at decentrialz.com.

Partnering to keep representative research alive

Federal guidance can move slowly, but the communities that clinical research is supposed to serve cannot afford to wait. Representative enrollment is a scientific standard, and the case for it does not depend on which draft or executive order is currently in force.

Advocacy groups that want to connect their communities to actively recruiting studies, or that want to discuss a structured referral relationship, can start at decentrialz.com.