Medical Trial Diversity Ignored by FDA in Fee Plan, Groups Say

Medical advocacy groups are insisting that stronger commitments to improving clinical trial diversity be included in the next user fee deal between the Food and Drug Administration and drugmakers, which will establish industry’s top priorities for the next five years.

An updated proposal implementing the fees companies pay to help get their cutting edge drugs to market wouldn’t hold them accountable for broadening the pool of patients who enroll in studies, the groups say. The disproportionate Covid-19 case and death rates among Americans of color underscore the need to make sure clinical trials reflect the actual population affected by a ...