AAMC Submits Letter to FDA on Race and Ethnicity in Clinical Trials

The AAMC and the AAMC Center for Health Justice submitted a letter on April 29 (PDF) to the Food and Drug Administration (FDA) in response to the draft guidance, Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. The goal of the draft guidance is to provide a standardized approach for collecting race and ethnicity data. Notably, the guidance references the White House Office of Management and Budget (OMB) Statistical Policy Directive No. 15 (SPD 15) which was updated in March 2024. The center submitted recommendations on the OMB’s proposed revisions to SPD 15 [refer to Washington Highlights, April 21, 2023].  

In its letter to the FDA, the AAMC highlighted key areas in the draft guidance that are consistent with the new updates to SPD 15, as well as areas that should be reevaluated. The AAMC also expressed support for the next steps the agency will take to finalize the draft guidance, recommending robust collaboration with other agencies implementing the revisions to SPD 15 and conducting clinical trials and studies.