FDA Halts Diverse Clinical Trial Guidance Amid Political Shift

The FDA has removed a draft guidance that mandated diverse testing of medicines and devices, following directives from the Trump administration to dismantle diversity initiatives. The move raises concerns about underrepresentation in trials, which may undermine scientific integrity and patient care quality.

The U.S. Food and Drug Administration (FDA) has removed draft guidance that required pharmaceutical companies to conduct clinical trials with diverse populations. This action is part of a broader move to retract diversity, equity, and inclusion initiatives within U.S. health agencies.

The removal follows a directive from President Donald Trump, mandating government agency leaders to dismantle diversity policies. The affected guidance was part of the 2022 Food and Drug Omnibus Reform Act and aimed to boost the participation of underrepresented groups in clinical trials.

Jeanne Regnante, a health equity consultant, stressed that inadequate representation in trials limits understanding of drug reactions across different demographics. The incident underscores growing concerns about the quality of healthcare research and practices.

(With inputs from agencies.)