Deciphering The FDA's Diversity Plan Updated Guidance

By Lya Rebelo, Commercial Enablement Manager

In April 2022, the US Food and Drug Administration (FDA) took a significant step in addressing health disparities with the release of draft guidance titled "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials." This guidance aimed to advise sponsors on developing Race and Ethnicity Diversity Plans to ensure the inclusion of adequate numbers of participants from underrepresented groups in US clinical trials. These groups include Black or African American, Hispanic/Latino, indigenous and Native American, Asian, Native Hawaiian and other Pacific Islanders, and other persons of color, who often bear a disproportionate disease burden compared to their representation in the general population.

Initially focusing on race and ethnicity, the April 2022 guidance laid the groundwork. However, the Food and Drug Omnibus Reform Act (FDORA), signed into law by President Joe Biden in December 2022, expanded these plans beyond demographics to encompass age groups, sex, and other relevant non-demographic factors.