The Controlled Substances Act (CSA) describes eight factors that need to be examined to assess the abuse potential (or liability) of drugs in clinical development that are active within the central nervous system (CNS). These factors encompass a wide range of topics regarding the drug, including the totality of its physical and behavioral effects, consequences to the individual and public health, its availability, and use patterns. The results of this analysis are a required part of any New Drug Application (NDA) submission to FDA for a product with CNS activity and is the basis for labeling and scheduling decisions. This presentation will review the history and provide an overview of the regulations surrounding the abuse potential evaluation of CNS-active drugs in the context of FDA’s 2017 final guidance on the topic. This will include a review of the step-wise approach to determine whether an abuse potential assessment is needed for a new drug, the types of scientific evidence that is required and studies that need to be conducted during drug development, and the processes involved with drug scheduling if deemed necessary and consistent with the CSA by FDA during its review of a sponsor’s NDA.

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