FDA Removes Guidance on Improving Clinical Trial Diversity Amidst DEI Policy Rollback
核心洞察
The FDA has removed draft guidance aimed at increasing the participation of underrepresented groups in clinical trials, aligning with a broader rollback of diversity, equity, and inclusion (DEI) initiatives.
The withdrawn guidance, stemming from the 2022 Food and Drug Omnibus Reform Act, would have required drug and device makers to set diversity enrollment goals for late-stage clinical trials.
Critics argue that the move impedes clinical research, undermines the FDA's scientific integrity, and threatens the quality of care for all patients, particularly underrepresented groups.
The U.S. Food and Drug Administration (FDA) has removed draft guidance from its website that aimed to improve the diversity of participants in clinical trials. This action coincides with a broader effort to dismantle diversity, equity, and inclusion (DEI) policies across U.S. health agencies, following directives from the Trump administration.
The now-removed "Diversity Action Plan" draft guidance, which originated from the 2022 Food and Drug Omnibus Reform Act, sought to significantly increase the involvement of underrepresented groups, including Black and Hispanic Americans, in clinical trials. The intention was to address the current imbalance where available evidence is predominantly based on data from white patients, potentially overlooking differences in drug responses and side effects across various populations.
The guidance would have mandated that drug and medical device manufacturers establish specific goals and strategies for enrolling individuals from diverse backgrounds in every late-stage clinical trial intended for U.S. regulatory review. The deadline for finalizing the guidance was set for June 2025.
"Poor representation in clinical trials reduces our understanding of drug responses and safety for all groups," stated Jeanne Regnante, a health equity life sciences consultant at Patient 3i LLC.
According to STAT, the removal of the guidance is part of a larger trend. The health website identified 10 examples of diversity and equity-related pages on FDA and other health agencies' websites that have been removed.
Dr. Robert Steinbrook, director of the health research group at Public Citizen, voiced strong concerns, stating 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 is among over 80 organizations that have expressed opposition to Robert F. Kennedy Jr's nomination to lead the top U.S. health agency.