The FDA’s guidance detailing diversity action plans for clinical trials that evaluate drugs, devices and other medical products has been taken down from the agency’s website.
In June 2024, under former President Joe Biden’s administration, the drug agency shared an outline of its proposed requirements that were expected to eventually become mandatory components of clinical studies. A final guidance document was never released publicly.
Numerous pages regarding diversity measures are no longer available across various agencies’ sites, including the National Institutes of Health, the National Cancer Institute, and the National Institute of Allergy and Infectious Diseases, a change first reported by STAT News. This includes the page for Project Equity, an effort from the FDA's Oncology Center of Excellence that expounded upon the agency’s 2021 guidance to increase clinical trial diversity.
Upon re-entering office, President Donald Trump launched his second term with a string of orders designed to eliminate diversity, equity and inclusion (DEI) practices, according to a Jan. 24 release from the White House. The new administration quickly placed federal DEI staffers on leave, as well.
Over the last several years, DEI initiatives have been a growing focus for biopharma, with many pharma giants in particular—such as Sanofi, Amgen, Merck & Co., Eli Lilly, GSK and Roche—rolling out new efforts to boost diversity in trials.
“Participants in clinical trials should be representative of the patients who will use the medical products,” former FDA commissioner Robert Califf, M.D., said last summer when the draft guidelines were shared. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”