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FDA Finalizes Guidance on Assessing New Drug Abuse Potential

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential. It provides the agency’s recommendations for timing and design of abuse-related studies, the types of studies that should be included in an abuse potential assessment submitted as part of a new drug application (NDA), and provides general recommendations for consulting with FDA about abuse potential assessment during the drug development process.

If a drug’s active ingredient is “CNS-active,” a new drug containing that ingredient will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act. The placement of a substance on Schedules II-V of the CSA is determined by substance’s relative abuse potential and the relative degree to which it induces psychological or physical dependence. Schedule I is reserved for substances with a high abuse potential, no currently accepted medical use, and a lack of accepted safety for use under medical supervision; ingredients in an FDA-approved product necessarily have a currently accepted medical use and therefore fall outside the purview of Schedule I.

According to this guidance, a new drug’s abuse potential may be derived from “results from a broad range of studies and other sources of information, such as the results of studies investigating chemistry, pharmacology, pharmacokinetics, animal and human behavior, abuse-related adverse events (AEs) in human studies, and reports of abuse from various sources, such as law enforcement, poison control centers, hospital emergency departments and medical examiners.” The FDA recommends that NDA applicants compile protocols and data from all abuse-related studies in the abuse potential assessment, along with a proposal for scheduling under the CSA, as part of the NDA.

If you would like more information on this or related matters, please contact Stephanie Trunk, Brian Malkin, Naomi Halpern, Emily M. Leongini, or the Arent Fox attorney who regularly handles your matters.