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Wednesday, September 10, 2025

Senator Marshall questions FDA on drug safety and AI alternatives

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Senator Roger Marshall, US Senator for Kansas | Official U.S. House headshot

Senator Roger Marshall, US Senator for Kansas | Official U.S. House headshot

U.S. Senator Roger Marshall of Kansas recently engaged with Dr. Jacqueline Corrigan-Curay, Acting Director at the Center for Drug Evaluation and Research for the United States Food and Drug Administration (FDA), during a Senate Committee on Health, Education, Labor, and Pensions hearing. The discussion focused on the safety of inactive ingredients in over-the-counter drugs and the potential use of artificial intelligence to replace animal testing.

Senator Marshall raised concerns about inactive ingredients in medications, highlighting that "the OTC monographs only list active ingredients." He noted public concern regarding artificial flavors and sweeteners. In response, Dr. Corrigan-Curay stated, “We certainly, anytime we identify that there’s an issue with an inactive ingredient, we would review it.” She mentioned existing guidances on color additives that allow firms to change their inactive ingredients.

The conversation also touched upon the use of AI as an alternative to animal studies. Senator Marshall suggested that AI could potentially provide more accurate results than traditional animal testing methods. Dr. Corrigan-Curay acknowledged ongoing efforts to reduce animal studies in monoclonal antibodies and alternatives already implemented for eye and skin irritation tests. She added that while challenges remain in validating non-animal approaches for multi-organ systems effects, progress is being made.

Senator Marshall requested evidence of progress in reducing animal studies: “Prove to me that you’re making progress in that; that would be very helpful.” Dr. Corrigan-Curay agreed to provide further information.

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