FDA drops webpages on initiative to improve clinical trial diversity

The Food and Drug Administration pulled draft guidance from its website requiring companies to test drugs and devices in diverse populations as part of the Trump Administration’s dismantling of diversity, equity and inclusion efforts at federal agencies. The Diversity Action Plan draft guidance seeks to increase participation of underrepresented groups, including Black and Latino Americans, in clinical trials. Available evidence overwhelmingly is based on white patients and may not account for differences in how drugs and devices work or what side effects they may cause in non-white populations. The guidance, set to be finalized in June, would require manufacturers to set goals and detail their strategies for enrolling people from underrepresented backgrounds for every late-stage trial for U.S. regulatory review. (Reuters article, 1/24/25)