Trump's Executive Orders

Trump's Executive Orders Threaten FDA's Diversity Requirements for Clinical Trials

The Trump administration's recent executive orders targeting Diversity, Equity, and Inclusion (DEI) programs have sparked concerns about their potential impact on the Food and Drug Administration's (FDA) efforts to implement the Diversity Action Plan (DAP) requirement for clinical trials. This requirement, mandated by the Food and Drug Omnibus Reform Act of 2022 (FDORA), is a critical step toward ensuring that clinical trials include diverse and representative populations, addressing longstanding disparities in medical research. However, the new executive orders, which aim to curtail DEI initiatives across federal agencies, could create significant hurdles for the FDA as it works to finalize and enforce the DAP guidance.

Statutory Mandate vs. Executive Orders: A Legal Tightrope

The FDA's Diversity Action Plan requirement is not just a recommendation — it's a statutory mandate under FDORA. This means the FDA is legally obligated to implement the DAP requirements, regardless of executive orders or administrative guidance. While executive orders can influence how federal agencies prioritize or enforce policies, they cannot override laws passed by Congress. In theory, this should protect the DAP from being derailed.

However, the political climate created by the executive orders could still pose challenges. The FDA already appears to be caving to political pressure to downplay its diversity initiatives by removing references to clinical trial diversity, health equity, and gender from its website in the days following the new executive orders, even as it works to fulfill its legal obligations. This tension between statutory requirements and political influence raises questions about how effectively the FDA can advance its diversity goals.

The Impact of New Executive Orders

The new executive orders targeting DEI programs could create a difficult environment for the FDA's implementation of the DAP requirements. Here's how:

• Resource Allocation: The FDA may face pressure to reduce funding or staffing for initiatives related to diversity in clinical trials. This could slow down the implementation process, making it harder to meet deadlines or enforce compliance.
• Political Climate: The administration's opposition to DEI programs could lead to reluctance within the FDA to aggressively enforce or promote the DAP requirements. Even if the guidance is finalized, the FDA might adopt a more cautious approach to avoid political backlash.
• Waiver Requests: Sponsors of clinical trials might feel emboldened to seek waivers from the DAP requirements more frequently, citing administrative burdens or other reasons. Under political pressure, the FDA could become more lenient in granting these waivers, undermining the goal of diverse representation.

The Binding Nature of the Guidance

Despite these challenges, the FDA's draft guidance on DAPs will have a binding effect once finalized, particularly regarding the form and manner of submission. This means that sponsors of clinical trials will be legally required to submit DAPs in accordance with the guidance.

While the executive orders may influence the FDA's approach to enforcement, they cannot negate the binding nature of the guidance itself. This provides a layer of protection for the DAP requirements, ensuring that diversity in clinical trials remains a legal obligation, even if the political will to enforce it wavers.

Potential Outcomes: Delays, Weakened Enforcement, and Advocacy

The interplay between the executive orders and the FDA's statutory mandate could lead to several outcomes:

• Delayed Implementation: The FDA may slow down the finalization or rollout of the DAP guidance due to political pressure or resource constraints. This could delay progress in addressing disparities in clinical trial participation.
• Weakened Enforcement: Even if the guidance is finalized, the FDA might adopt a more lenient approach to enforcement, such as granting more waivers or reducing oversight of sponsors' compliance. This could dilute the impact of the DAP requirements.
• Continued Advocacy: Despite the executive orders, stakeholders in the medical and research communities—including patient advocacy groups, researchers, and pharmaceutical companies—are likely to continue pushing for robust implementation of the DAP requirements. Their efforts could help counterbalance political pressures and keep diversity in clinical trials on the agenda.

Industry and Stakeholder Response

Pharmaceutical companies and clinical research organizations often align their practices with federal guidelines and priorities. The Trump administration's stance on DEI could lead some stakeholders to deprioritize diversity in clinical trials, further complicating the FDA's efforts to enforce its Diversity Action Plan.

On the other hand, many in the medical and research communities recognize the importance of diversity in clinical trials and may continue to advocate for inclusive practices, regardless of the administration's policies. This could create a divide between those who follow the letter of the law and those who go above and beyond to ensure equitable representation.

Navigating Challenges for Equitable Research

While the new executive orders targeting DEI programs create significant challenges for the FDA's implementation of the Diversity Action Plan requirements, the statutory mandate under FDORA ensures that the FDA must finalize and enforce the DAP guidance. The binding nature of the guidance means that sponsors of clinical trials will be required to submit DAPs, but the FDA's approach to enforcement may be influenced by the political climate.

In the short term, the FDA may face delays or adopt a more lenient stance on enforcement, potentially weakening the impact of the DAP requirements. However, the statutory mandate provides a foundation for continued advocacy and progress. Future administrations could reverse the current executive orders, allowing for more robust implementation of diversity initiatives in clinical trials.

The ultimate success of the DAP requirements will depend on the FDA's ability to navigate these challenges and prioritize equitable representation in clinical research. As stakeholders continue to push for inclusivity, the hope is that diversity in clinical trials will remain a cornerstone of medical progress, even in the face of political headwinds.

The Role of Technology in Building Trust and Engagement

Amid these challenges, solutions like SMi Engage are simplifying clinical trial enrollment, engagement, and retention through customized video-based training designed for participants. By delivering patient-focused education, SMi Engage builds trust, encourages active involvement, and supports the enrollment of representative populations, making clinical trials more inclusive and accessible

This approach enhances retention and fosters stronger connections between researchers and participants, aligning with the goals of the FDA's Diversity Action Plan. As the FDA works to implement its DAP requirements, tools like SMi Engage demonstrate how technology can bridge gaps in trust with high-quality participant-centric education, ensuring clinical trials are both diverse and patient-centered AND meet retention goals.

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