Behavioral pharmacology contributions to regulation of drug and tobacco products by the Food and Drug Administration.

Abstract

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.

Behavioral economic research in addiction as an area of growth for the experimental analysis of behavior.

“…Behavioral economic purchase tasks are being developed for e-cigarettes (Cassidy, Tidey, Colby, Long, & Higgins, 2017), which are electronic devices that deliver nicotine-containing aerosol without combustion, and human laboratory methods for evaluating the impact of these products on demand for cigarettes are enjoying a resurgence (Grace, Kivell, & Laugesen, 2015; Quisenberry, Koffarnus, Epstein, & Bickel, 2017). Such behavioral economic assessments have become part of how such products are evaluated by the Food and Drug Administration (Henningfield, Buchhalter, & Fant, 2016; Tidey, Cassidy, Miller, & Smith, 2016), illustrating the increasing relevance of these methods in policy applications.…”

Experimental analysis of behavior and tobacco regulatory research on nicotine reduction

“…As noted in the previous section, the FSPTC Act permits the “Secretary to enter into contracts for research”. The FDA has a long history of using research from behavioral pharmacology to develop policy (for a review see Henningfield, Buchhalter, and Fant, ). As an example, the Federal Register Docket no.…”

“…Perhaps one of the most powerful examples of the applied or translational importance of research in behavioral pharmacology was recounted by Henningfield et al () regarding the Philip Morris behavioral pharmacologists DeNoble and Mele that demonstrated intravenous self‐administration of nicotine in rats:

DeNoble and Mele believed that their work might contribute to the development of less harmful cigarettes but senior legal counsel for Philip Morris were concerned that the scientists had essentially shown that nicotine looked like heroin in this model and questioned why they “should be allowed to risk a billion dollar enterprise for lever‐pushing rats” (DeNoble, 1994; Mele, 1994). DeNoble and Mele were ordered to turn over all data and retract manuscripts submitted for publication.

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“…Perhaps one of the most powerful examples of the applied or translational importance of research in behavioral pharmacology was recounted by Henningfield et al (2016) regarding the Philip Morris behavioral pharmacologists DeNoble and Mele that demonstrated intravenous self-administration of nicotine in rats:…”

“…The Henningfield et al () paper from which we pulled this quote is titled “Behavioral pharmacology contributions to regulation of drug and tobacco products by the Food and Drug Administration”. This paper is an excellent read for a broader discussion of the FDA and how it uses the science of behavioral pharmacology to make policy decisions for drugs acting on the central nervous system.…”