This Law is Pushing for More Diversity in Clinical Trials

For decades, there has been a lack of diversity in clinical trials for new drugs and medical treatments. This lack of representation of different racial and ethnic groups has contributed to health disparities and an incomplete understanding of how new therapies may impact diverse populations. However, a new law passed aims to change that by requiring drug companies to develop specific plans to enroll more underrepresented groups in their clinical trials. What is the FDORA Act? The new requirements are part of the Food and Drug Omnibus Reform Act of 2022, known as the FDORA Act. As Dr. Lola Fashoyin-Aje, a medical oncologist and FDA official, explained in a BDO panel discussion, “FDORA amends the Food, Drug and Cosmetic Act” to give the FDA more authority to ensure diversity in clinical trials. “We are very excited about having this new tool to really engage sponsors on very early discussions about their strategy in very specific ways that really keeps them accountable to particular goals and to the measures that they will be implementing to achieve those goals,” said Dr. Fashoyin-Aje. How does the FDORA Act work? Under FDORA, drug companies must submit detailed diversity plans outlining their goals and strategies...