Behavioral Pharmacology Contributions to Regulation of Drug and Tobacco Products by the Food and Drug Administration

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Behavioral pharmacology methods and strategies are increasingly relied upon by the Food and Drug Administration (FDA) for its regulation of drug and tobacco products due to the reliability, validity, and generalizability of the findings. FDA is required to regulate products on the basis of their scientific foundation and public health implications. Sponsors submitting applications for approval of drug and tobacco products and FDA have found behavioral pharmacology to be an invaluable scientific approach to guide decision making concerning product development and regulation. FDA’s guidance to industry documents recommend behavioral pharmacology approaches including self-administration and drug discrimination to evaluate reinforcing effects of substances to be submitted for review. This commentary discusses elements of behavioral pharmacology that have led to its reliance by FDA. Three specific areas of FDA reliance are provided to exemplify FDA’s reliance on behavioral pharmacology methods: drug abuse liability assessment, opioid abuse-deterrent assessment, and tobacco product regulation.

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