or years, clinical research has wrestled with the fundamental challenge of ensuring that the subjects enrolled in studies reflect the patients who will ultimately use the therapies. Diversity, equity, and inclusion (DEI) initiatives reflected in FDA guidance, NIH grantmaking, and/or sponsor-led action plans were meant to push the industry towards that ideal. However, the evolving legal and political landscape in the United States has pushed DEI to effectively be on life support.

Recent US court rulings and administrative actions paint a picture of reversal. A federal judge ordered the CDC, FDA, and HHS to restore certain removed website data, criticizing the government’s attempt to control the narrative of public health information. Another judge struck down DEI programs in schools, signaling a judiciary skeptical of race- and gender-based initiatives. The Supreme Court, meanwhile, allowed the termination of $783 million in NIH grants tied to DEI initiatives. It is worth noting that Congress codified diversity action plans in the Food and Drug Omnibus Reform Act of 2022 (FDORA), meaning that for many pivotal trials, diversity planning is not just policy but a requirement in the law. Nevertheless, the FDA’s own efforts to make representative clinical trials using diversity action plans were eliminated in January 2025, only to be reinstated in February 2025 under court order.

At first glance, these shifts suggest that DEI in clinical research has lost its footing. But history, law, and regulatory practice suggest otherwise.

A Familiar Pendulum

Policy swings are nothing new. Just as with advertising regulation, drug pricing initiatives, or even broader civil rights issues, the pendulum swings back and forth between expansion and contraction depending on the political environment. While it is fair to say that the DEI rollback we’re witnessing now is dramatic, it is unlikely to be permanent.

The parallel to Marbury v. Madison is apt. That case pit two branches of government against each other and forced a reconciliation of roles, boundaries, and authority. Similarly, what we are seeing now is not the “death” of DEI but rather a struggle between the executive branch, which often pursues policies that may be seen as exclusionary, and the judiciary, which is testing the constitutional boundaries of such efforts. The likely outcome is therefore unlikely to be a wholesale dismantling of DEI but instead a redefinition of its permissible contours.

FDA’s Position: Regulatory Whiplash

The FDA’s diversity action plan guidance illustrates the uncertainty. Initially issued in June 2024 to encourage sponsors to detail how they would include underrepresented populations in trials, the guidance was withdrawn before again being reinstated. There is no evidence, however, that this guidance is being enforced. This back-and-forth underscores a broader truth that the agency recognizes the importance of diversity in generating reliable safety and efficacy data.

Ignoring DEI raises scientific and regulatory risks. A therapy tested primarily in homogenous populations may later reveal safety signals or efficacy gaps in underrepresented groups. Such gaps invite post-marketing scrutiny, liability, and even product withdrawal. The FDA’s reinstatement of the guidance reflects a recognition that diverse data is central to sound science.

The Judicial Shift: Arbitrary and Capricious?

Sponsors should also note the broader administrative law implications. Agencies that swing wildly between policy positions risk losing credibility with courts and regulated entities alike. When an agency issues guidance one day, withdraws it the next, and reinstates it a month later, it invites judicial skepticism. Courts may not be deciding the scientific value of DEI, but they are increasingly scrutinizing whether agencies are acting consistently and rationally.

This judicial skepticism doesn’t erase the underlying scientific need for diversity. It only forces agencies to tread carefully in mandating or incentivizing it.

Why Sponsors Shouldn’t Disband DEI Efforts

Faced with these reversals, some sponsors may be tempted to dismantle DEI programs, halt diversity planning, or scale back recruitment efforts targeting underrepresented populations. That would be a mistake.

Science Demands Diversity
Whether federal policy mandates it or not, the science of drug development requires representative data. Without it, sponsors risk gaps that could later derail approvals or undermine market uptake or expose underrepresented patients to drugs that are not effective or safe for them.

Regulatory Continuity
By definition, guidances are nonbinding. Accordingly, even if the DEI guidance is formally rescinded in the short term, future administrations or courts may reinstate it and deem companies not adhering to laws like FDORA to be noncompliant. Sponsors who maintained DEI programs will be better positioned to comply without having to scramble to restore their compliance.

Global Trends
Outside the US, regulators such as the EMA continue to emphasize inclusion of diverse patients in clinical trials. International guidelines, including ICH E6 (R3), emphasize the importance of representative enrollment, highlighting that diversity in clinical trials is a global expectation. Multinational trials that ignore DEI may face hurdles abroad even if US enforcement relaxes.

Reputation and Market Access
Patients, advocacy groups, and payers increasingly expect evidence of inclusivity. Sponsors who abandon DEI risk reputational harm, while those who maintain it can highlight their commitment to equitable access.

Lessons from Gender Nonconformity Research

The argument that ignoring gender nonconforming populations in research holds back science and innovation remains relevant today. Whether it’s transgender individuals excluded from oncology trials, women underrepresented in cardiology studies, or racial minorities underenrolled in gene therapy research, the consequences of exclusion are the same: therapies may not perform as expected in the real world.

These scientific gaps don’t vanish when DEI programs are curtailed. They remain as risks that savvy sponsors will mitigate, regardless of whether the FDA currently has the political leeway to enforce diversity plans.

Waiting Out the Storm

The prudent path for sponsors is not abandonment but patience. It would be prudent for sponsors to continue developing diversity action plans, maintain outreach to underrepresented populations, and keep building internal systems to track enrollment by demographics. While the current legal climate is undoubtedly a storm, the global nature of drug development and the sheer interest of science demands that it is not the end of the journey.

As with Marbury v. Madison, the conflict between branches of government will eventually resolve into a new equilibrium. Sponsors who treat DEI as optional during this interim period will find themselves scrambling when the pendulum swings back. On the other hand, sponsors who treat DEI as essential will not only stay ahead of regulatory shifts but will also build trust with patients and payers.

Conclusion

DEI has undoubtedly taken a backseat in 2025, as evidenced by judicial pushback, withdrawn guidances, and terminated grants. But sponsors should resist the urge to view this as the end of the road. These dramatic shifts rarely last. Just as Marbury v. Madison ultimately created a lasting framework out of temporary chaos, today’s turbulence will eventually yield a reconciled, stable approach to diversity in research.