Diversity in Clinical Trials at FDA Gets a Boost From New Law

Drug and device companies should prepare now for new legal requirements aimed at improving clinical trial diversity—even as they wait for more action from the FDA.

The 2023 omnibus spending bill enacted last month (Public Law 117-328) requires diversity action plans for the clinical trials used by the Food and Drug Administration to decide whether drugs are safe and effective.

The idea is to encourage investigators to develop a strategy for reaching a broad study population on the front end, instead of either failing to do so altogether, or acting later and increasing an already lengthy and costly ...