FDORA And The Diversity Action Plan Requirement – Are You Prepared?

By Rashida Challenger, Meghan Patterson, and Michael Fusakio, Ph.D.

The U.S. Congress has recently acted to enhance diversity in clinical trials, necessitating clinical trial sponsors for most drug and device studies to submit a Diversity Action Plan to the U.S. Food and Drug Administration (FDA). This directive results from the Food and Drug Omnibus Reform Act (FDORA) and will pertain to trials commencing enrollment 180 days after the FDA finalizes its guidance on this matter.

Diversity in trials is pivotal as individual responses to treatment can vary based on factors like age, gender, weight, race, and ethnicity. Clinical trials rely on volunteers, and including participants from diverse backgrounds helps assess treatment safety and efficacy for a broad range of communities.

The journey leading to this milestone has been gradual, so let's revisit the path that brought us here.