Eshoo Statement on New FDA Guidance for Diversity in Clinical Trials

April 13, 2022
Press Release

WASHINGTON, D.C. –Today, Representative Anna G. Eshoo (D-CA), Chairwoman of the Health Subcommittee, released the following statement in response to the Food and Drug Administration’s draft guidance recommending that sponsors of medical products develop and submit to the agency a Race and Ethnicity Diversity Plan showing how they plan to include diverse populations in their clinical trials:

“In February, I introduced with Representatives Robin Kelly (D-IL) and Brian Fitzpatrick (R-PA), H.R. 6586, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which requires drug and device companies to show how they will include diverse populations in their clinical trials by reporting to FDA a ‘diversity action plan’ with targets by demographic subgroups. The legislation is supported by a broad coalition of research and patient organizations. Today, the FDA issued draft guidance modelled off of the DEPICT Act recommending that sponsors develop and submit to the agency a ‘Race and Ethnicity Diversity Plan.’

 “While the FDA’s draft guidance is important progress, it is still a non-binding recommendation. There is no statutory or regulatory requirement for diversity in clinical trial participants. That’s why Congress must pass the DEPICT Act. Diverse clinical trials are not only fair and just – it’s good science. I look forward to working with my colleagues in Congress and the FDA to pass and implement the DEPICT Act to make good science the rule, not the recommendation.”