E&C Democratic Leaders Urge FDA to Advance Clinical Trial Diversity Efforts
Pallone, Eshoo, and Castor Wrote to the Agency to Encourage Publishing of Draft Guidance on Diversity Action Plans As Soon As Possible
Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Anna G. Eshoo (D-CA), and Oversight and Investigations Subcommittee Ranking Member Kathy Castor (D-FL) wrote to Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. to urge the agency to move forward with guidance to improve the diversity of populations represented in clinical trials.
“Ensuring that medical products are safe and effective for all populations intended to benefit from them hinges on their clinical testing in diverse populations,” the members wrote. “Inclusive clinical trial enrollment practices can also increase patients’ confidence in effective new treatments. Yet, despite FDA’s current recommendations on how to operationalize diversity plans, historically marginalized populations, such as certain racial and ethnic groups and women, are still underrepresented in many clinical trials. In fact, at least one report shows that inclusion of Black patients in clinical trials declined over the last decade.”
Congress passed new requirements in the Food and Drug Omnibus Reform Act of 2022 (FDORA) that require drug and medical device manufacturers to submit diversity action plans to FDA ahead of pivotal clinical trials. The law required FDA to publish draft guidance on the format and content of these diversity action plans no later than December 29, 2023. However, the draft guidance has yet to be made available, which delays implementation of the law’s clinical trial diversity provisions.
“We recognize and applaud your stated commitment to promoting diversity of clinical trial participants, as well as the work FDA has done to facilitate recruitment and inclusion of underrepresented populations,” the Democratic Committee leaders continued. “However, as you know, much more work needs to be done. We urge you to prioritize FDORA’s statutory requirements so patients can see the benefit of representative clinical trials as soon as possible.”
Read the full letter HERE.
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