Legal Expert Weighs In On New US Mandate To Diversify Clinical Trials

The omnibus spending bill passed at the end of 2022 requires clinical trial sponsors to submit a diversity action plan to the US Food and Drug Administration. Attorney Faraz Siddiqui, who coauthored a blog post on the new regulation, spoke to Medtech Insight about the requirement and the push to increase diversity.

Diversity in Clinical Trials
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Advocacy groups and other stakeholders argue that for too long, clinical trials have lacked participants from racial minorities and other socially disadvantaged groups. Last month, the US Congress passed a new law that could begin reversing this trend.

A provision in the omnibus spending package passed in December, “The Food and Drug Omnibus Reform Act (FDORA),” requires sponsors of most drug and device clinical studies to include...

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