RARE Daily

Democrats Call on Califf to Advance Guidance on Clinical Trials Diversity

February 21, 2024

Rare Daily Staff

Democratic members of the House Committee on Energy and Commerce sent a letter for U.S. Food and Drug Commissioner Robert Califf to urge the agency to issue guidance to improve the diversity of populations represented in clinical trials as soon as possible.

“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.”

The letter said that 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 2022 that require drug and medical device manufacturers to submit diversity action plans to the FDA ahead of pivotal clinical trials. The law required the agency to publish draft guidance on the format and content of these diversity action plans no later than December 29, 2023. Nevertheless, the draft guidance has yet to be made available.

The letter acknowledges work the FDA has done to improve clinical trials diversity including publishing nonbinding recommendations on clinical trials diversity planning and holding a public workshop last November to solicit input. But in the absence of the guidance, they said further implementation of efforts to improve diversity in clinical trials is being delayed.

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