Are You Ready? The New FDA Requirement for Diversity Action Plans in Drug and Device Clinical Investigations

On December 29, 2022, the Consolidated Appropriations Act, 2023 was signed into law. Tucked into this legislation, SEC. 3601 - DIVERSITY ACTION PLANS FOR CLINICAL STUDIES amends the Federal Food, Drug and Cosmetic Act (FD&C Act) by requiring diversity action plans for specific FDA-regulated clinical investigations. The FD&C Act now requires sponsors of clinical investigations of a new drug to submit diversity action plans for phase 3 and other pivotal studies of new drugs (excluding bioavailability or bioequivalence studies). Sponsors of medical devices must submit diversity action plans for any clinical investigation intended to determine safety and effectiveness of a device for which an Investigational Device Exemption (IDE) is required as well as clinical investigations for which an IDE submission is not required; i.e., clinical investigations conducted under the Abbreviated Requirements of 21 C.F.R. § 812.2(b). The requirements for diversity action plans present significant legal and operational considerations for clinical study sponsors.

In this roundtable we will discuss:

• What we expect to see from FDA and the timeline for implementation and requirements for FDA to seek public input;
• Requirements for diversity enrollment goals specific to each study;
• Implications of inclusion of the estimated prevalence or incidence of the medical condition in the enrollment goal;
• Challenges of specification of age group, sex, race, geographic location, socioeconomic status, and more in the enrollment target;
• What to prepare for and what to do now