Anna G. Eshoo

06/26/2024 | Press release | Distributed by Public on 06/26/2024 21:44

Rep. Eshoo Applauds New FDA Draft Guidance for Diversity in Clinical Trials

Washington, D.C. - Health Subcommittee Ranking Member Anna G. Eshoo (CA-16) made the following statement in response to the Food and Drug Administration's (FDA) draft guidance to boost diversity in clinical trials:

"Two years ago, my Diverse and Equitable Participation in Clinical Trials (DEPICT) Act was signed into law, creating the first-ever requirement in law for drug and device companies to show how they will include diverse populations in their clinical trials. Today, the FDA issued draft guidance required by the DEPICT Act to outline what information should be included in the Diversity Action Plans submitted by sponsors of clinical trials involving drugs and medical devices to the FDA. The draft guidance also details when in the clinical trial enrollment process Diversity Action Plans should be submitted to the FDA.

"Clinical trials have failed to achieve a level of diversity that reflect the American population for decades. I applaud the FDA's steps to implement my legislation to address this inequality and look forward to the agency finalizing guidance on the Diversity Action Plans to ensure clinical trials are representative of all Americans."

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