Bass, Berry & Sims attorney Clint Hermes was quoted in a Law360 Healthcare Authority article examining the FDA’s draft guidance released on June 26 that mandates clinical trial sponsors to submit to the FDA diversity action plans (DAPs) to improve the diversity of clinical study participants. The guidance was mandated by the Food and Drug Omnibus Reform Act of 2022 (FDORA). It highlights the importance of considering various demographic factors and indicates that waivers will be rare, emphasizing the agency’s commitment to enhancing diversity in clinical research.

In the article Clint noted that the guidance carves out early-phase exploratory studies of medical devices, focusing DAP requirements on later-stage studies.

“At the end of the day, they are proposing to not enforce FDORA’s requirements for early-stage device studies,” Clint said. Although early studies can guide how sponsors will structure future research on a product’s safety or efficacy or whether that research will be conducted at all, Clint noted that these early studies are not “themselves those safety and efficacy studies.”

The full article, “4 Takeaways From FDA’s Clinical Trial Diversity Guidance,” was published July 2 by Law360 Healthcare Authority and is available online (subscription required).

Clint is the Chair of the firm’s Clinical Research practice. For more information about this topic, check out the firm’s recent alert FDA’s Diversity Action Plans for Clinical Trials: Key Deadlines and Compliance Requirements.