WASHINGTON — Sometime next year drug and medical device companies will have to tell the Food and Drug Administration how they plan to include people of color in clinical trials. But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT.
Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials. The FDA is set to draft guidance for those plans by the end of the year. If everything proceeds on time, drug and medical device makers will be required to submit plans for meeting diversity standards by the end of March 2025.
To ensure that drugs work for everyone, they must be tested on a representative sample of people. Poor clinical trial diversity creates gaps in the understanding of diseases and the drugs that treat them. The knowledge gaps make it difficult for doctors and patients to make the right decisions about their health care, and they undermine drug development, according to the National Institutes of Health.