Opinion: FDA: Don’t rush publishing your diversity guidance plan. Take your time and do it right
When Congress passed the Food and Drug Omnibus Reform Act (FDORA) in December 2022, it was hailed as a landmark step toward codifying diversity and inclusion in clinical trials. Under FDORA, sponsors of Phase 3 and other pivotal trials are required to submit a diversity action plan to the Food and Drug Administration along with their study protocol. The FDA’s goal is to ensure that enrollment goals include clinically relevant study populations.
The FDA is also required to publish guidance on diversity action plans. But nearly half a year after a Dec. 29, 2023, deadline for the agency to circulate a draft, the biopharma industry is still waiting for it. If this means the FDA is trying to get this right, we think the delay is OK.
