FDA Pulls Web Pages on Diversity With Clinical Trials

The Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and devices in diverse populations as part of a purge of diversity, equity and inclusion efforts at federal health agencies.

The move, first reported by health website STAT, follows President Donald Trump's executive order Tuesday directing government agency chiefs to dismantle DEI policies largely relating to employment at federal agencies, federal contractors and in the private sector.

The FDA's Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act.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 might not account for differences in how drugs and devices work or what side effects they might 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 set for U.S. regulatory review. It was set to be finalized by June 2025.

"Poor representation in clinical trials reduces our understanding of drug responses and safety for all groups," said Jeanne Regnante, a health equity life sciences consultant at Patient 3i LLC.

At midday Friday, Reuters could not access the FDA's June 26 draft guidance on the agency's website. It was still accessible on the U.S. government's regulation.gov website.

The FDA declined to comment, citing a pause on most mass communications from federal health agencies introduced by the new Trump administration as it reviews their processes.

Federal health agencies were instructed this week not to engage in non-urgent communications until Feb. 1.

The guidance was just one of several federal government efforts to include more diverse populations in clinical research and medicine that have been removed from public view. Other links that appeared to have been scrubbed included a podcast on health equity and a discussion paper on health equity in medical device trials.

Using the Internet Archive, STAT identified 10 examples of diversity and equity-related pages on the websites of the FDA and other health agencies that were removed.

"The fact that this is happening is very disturbing," said Dr. Robert Steinbrook, director of the health research group at Public Citizen, a consumer advocacy group.

Steinbrook said in a statement that the Trump administration's opposition to DEI initiatives is "impeding clinical research, undermining the FDA's scientific integrity and threatening the quality of care for all patients."

Public Citizen urged incoming FDA leadership to stay the course in improving clinical research and patient care.