Kennedy Commits to Diverse Clinical Trial Regulations Amid FDA Scrutiny

Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his confirmation hearing. This follows the removal of diversity information from the FDA website. The proposed guidance aligns with legislation aimed at increasing trial participation from minority groups by 2025.

During his confirmation hearing, Robert F. Kennedy Jr., President Donald Trump's nominee for the U.S. health agency, assured senators that he will implement regulations to boost diverse patient inclusion in clinical trials.

This promise comes after the FDA removed draft guidance and diversity information from its site. Kennedy, nominated to head the Department of Health and Human Services, confirmed his commitment to finalizing the congressionally-mandated guidance when questioned by Senator Ben Ray Lujan.

The Diversity Action Plan, required by the 2022 Food and Drug Omnibus Reform Act, seeks to address the lack of minority representation in clinical trials. The guidance mandates drug and device companies to outline inclusion strategies for approval processes, with finalization set for June 2025, despite its disappearance from the FDA website remaining unexplained.

(With inputs from agencies.)