Consolidated Appropriations Act, 2023, Requires Sponsors to Submit Diversity Plans with Phase III Study Design

FDA’s Draft Guidance to Serve as Starting Point for Plan Development Until Finalization 

This article is a part of our CTSC DEI Resource Highlight series. 

In April 2022, the Department of Health and Human Services Food and Drug Administration (FDA) released draft guidance for industry regarding diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials. The FDA will receive $3.5B in appropriations from The Consolidated Appropriations Act, 2023. With a push for quicker development and approval of medical products and simultaneous prioritization of diversity in clinical trials, it will be even more important to ensure that studies are intentional and able to execute to achieve diversity necessary to support generalization of study results.

The Food and Drug Omnibus Reform Act of 2022 was included in the omnibus bill with provisions aimed at promoting diversity in clinical trials, the growth of decentralized clinical trials, and streamlining of clinical trials.

Two weeks before the Act passed, our Assistant Director of Strategic DEI & Health Disparities, Gelise Littlejohn Thomas, JD, MS, wrote an article published in Clinical Leader titled Don’t Wait on Legislation to Leverage DEI that includes DEIA strategies to consider and implement. Interested in taking the next step with incorporating research equity, accessibility, diversity, and inclusion principles and values into your research program and studies? Schedule a READI Consultation today.