FDA plan to diversify clinical trials raises some concerns

Aug 29 2014

Women's advocacy groups complain that the plan doesn't have "teeth" needed to make a change.

The Wall Street Journal: FDA Is Chastised Over Its 'Action Plan' To Diversify Clinical Trial Participation
In response to a law passed two years ago, the FDA was directed to assess the extent to which women and minorities are represented in clinical trials and also devise a plan to bolster their participation. ... the FDA released its plan the other day and it was met with what could best be described as faint praise. In particular, a pair of women's advocacy groups says the biggest issue is that the so-called Action Plan lacks the sort of teeth needed to generate real change. They also complain the plan fails to require drug and device makers to contain specific demographic information in product labeling (Silverman, 8/28).