By Julie Steenhuysen
CHICAGO (Reuters) – Robert F. Kennedy Jr., President Donald Trump’s pick to lead the top U.S. health agency, told U.S. senators during his confirmation hearing on Wednesday that he would finalize regulations aimed at increasing the participation of diverse patient populations in clinical trials.
The comment followed a purge last Friday of draft guidance and other diversity-related information from the U.S. Food and Drug Administration’s website. Kennedy is nominated to run the U.S. Department of Health and Human Services, which oversees FDA.
Asked by Democratic Senator Ben Ray Lujan whether he would commit to finalizing the guidance on clinical trial diversity mandated by Congress, Kennedy replied, “Yes.”
The FDA’s Diversity Action Plan draft guidance to drugmakers and medical device companies fulfills a requirement laid out in the 2022 Food and Drug Omnibus Reform Act.
Historically, most available evidence from clinical trials is based largely on white patients and may not account for differences in how drugs and devices work, or what side effects they may cause, in various patient populations. The law aims to increase participation of underrepresented groups, including Black and Hispanic Americans.
The guidance would require drug and device makers to set goals and detail their strategies for enrolling people from diverse populations for every late-stage clinical trial of medicines and medical devices slated for U.S. regulatory review.
The guidance was due to be finalized by June 2025, and it is not clear why it was removed from the FDA website.
HHS and FDA spokespeople declined to comment, citing a communications moratorium imposed by the Trump administration until Feb. 1.
(Reporting by Julie Steenhuysen; Editing by Bill Berkrot)
Comments