Jan. 24, 2025, the U.S. Food and Drug Administration (FDA pulled draft guidance from its website requiring companies to test medicines and devices in diverse populations as part of a purge of diversity, equity and inclusion efforts at U.S. health agencies.

The FDA’s Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act. It aims to significantly increase participation of underrepresented groups, including Black and Hispanic Americans, in clinical trials, recognizing that most available evidence is based largely on white patients and therefore may not account for differences in how drugs and devices work or what side effects they may cause in various populations.

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 slated for U.S. regulatory review. It was due to be finalized by June 2025.