FDA originally published final guidance on the collection of race and ethnicity data in clinical trials in 2016, in response to the Office of Management and Budget (OMB) Statistical Policy Directive 15, Revisions to the Standards for the Classification of Federal data on Race and Ethnicity, which was developed to provide a common framework for uniformity and consistency in the collection and use of data on race and ethnicity by federal agencies. OMB stated that the recommended race and ethnicity categories were not anthropologically or scientifically based designations, but were instead categories that describe the sociocultural construct of our society. FDA’s update of the guidance was spurred in part by an OMB-initiated review of OMB Policy Directive 15.

FDA’s new revised draft guidance retains much of the content from the 2016 version. It maintains the original intent of FDA’s 2016 recommendations to sponsors on the presentation of demographic data in drug, biologics, and device marketing applications, improving the completeness and quality of demographic data collection and reporting. This version also streamlines the 2016 guidance by eliminating much of the historical background that gave context to FDA’s recommendations.

FDA continues to recommend that participants self-report their own race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, or White) and ethnicity (as either Hispanic or Latino, or Not Hispanic or Latino) and that they be permitted to designate a multiracial identity. In situations where the collection of self-reported designations is not feasible, the guidance recommends that study teams request this information from a member of the participant’s family rather than assigning a race and/or ethnicity to a participant. Newly added is an endorsement of using real world data sources to obtain this information, such as medical records, provided that the information contained in the record is verified by the participant.

The latest guidance also wades into the inclusion of race and ethnicity information in proposed product labeling, suggesting that the Clinical Studies and Adverse Reactions sections list the baseline demographics of the study population.

We continue to await the diversity action plan guidance from FDA, which was originally expected to be published in December 2023, and which is mandated by the Food and Drug Omnibus Report Act of 2022 (FDORA).

Comments on this new draft version are due on April 29, 2024. If you have any questions on ensuring diversity in your clinical studies, or on clinical trial protocols more generally, feel free to contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.