The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • March 30, 2017

In January 2017, the FDA finalized their guidance for industry reviewing the requirements for the assessment of abuse potential of drugs. As stated in the guidance, drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce specific effects such as euphoria (or other changes in mood), hallucinations and effects consistent with CNS depressants or stimulants.

Unlike the previous draft version, issued in 2010, this guidance also further elaborates on the criteria for evaluating physical dependency and withdrawal symptoms. The guidance lays out the pathway for determining whether or not human abuse potential evaluation assessment will be required and generally recommends that sponsors evaluate this need along with the FDA during the end-of-phase II meeting. Details are provided in the guidance with respect to the division’s review of abuse and dependence related data and outlines the process taken to schedule drugs.

The guidance outlines the abuse related data from chemistry and nonclinical studies and details the types of preclinical studies that are commonly used to evaluate abuse and dependence potential. The section on human studies discusses adverse events of special interest and focuses on methods to summarize these key events across a clinical trial program. Human abuse potential studies, studies that evaluate cognition and performance and clinical evaluation of physical dependence are discussed. Lastly the guidance discusses post-marketing and illicit drug abuse data and lists common data sources for such findings.

The purpose of this webinar is to evaluate and discuss the methodological approaches outlined in the guidance and highlight several key areas that may warrant further consideration when designing and planning for such studies. Guest speakers are industry leaders in the evaluation of preclinical and clinical abuse and dependence evaluation.


Dr. Jack E. Henningfield, PhD, Vice President, Research, Health Policy, Abuse Liability, PinneyAssociates

Dr. Henningfield was trained in abuse liability assessment and related sciences in the Psychopharmacology Program at the University of Minnesota and the Behavioral Biology Program of The Johns Hopkins University in the 1970s. Then, at the National Institute on Drug Abuse (NIDA), which contributes to Controlled Substances Act drug scheduling, he served as Chief of the Clinical Pharmacology Branch, and the Abuse Potential Assessment Section and contributed to NIDA’s drug scheduling recommendations. In 1996 he left NIDA to consult on these issues with PinneyAssociates.

Dr. Henningfield has published more than 400 articles and books, and contributed to abuse potential assessment monographs from NIDA in the 1980s, FDA’s first draft guidance in 1990, and expert reviews and special conferences on abuse potential involving FDA in the 2000s leading to FDA’s 2010 draft guidance and the 2017 Final Guidance. His decades of research, substance and product evaluation, and contribution to regulation provide his expert perspectives on the science base, the regulatory implications, and the overall value, as well as the limitations of the Final Guidance.

In an interview for a recent Bloomberg Pharmaceutical Law and Industry Report on the Final Guidance Dr. Henningfield stated: “It is relevant to every new drug that affects the brain whether it is for pain, Alzheimer’s, ADHD, addiction alertness, anxiety, depression, cognition, sleep and wakefulness, obesity, performance and more.” and that “this is very big from the perspectives of public health, medicine, public safety, and the willingness of pharmaceutical developers to invest” in new medicines.

Dr. David J. Heal, PhD, DSc, FRSC, FBPhS, Executive Director, RenaSci Ltd.

David Heal is currently an Executive Director of RenaSci Consultancy Ltd; a company that he co‑founded in 2001. RenaSci is an independent provider of consultancy and experimental services to the pharmaceutical industry in the therapeutic areas of diabetes, obesity and CNS disorders. David started his career in academic research at the MRC Clinical Pharmacology Unit, Oxford University before transferring to pharmaceutical R&D in the mid-1980’s. During his career at Boots Pharmaceuticals and BASF Pharma, he led teams which put several novel compounds successfully through clinical development, including the anti‑obesity drug, sibutramine, (Meridia) and the antipsychotic, zotepine (Zoleptil). Since co‑founding RenaSci, he has assisted pharmaceutical industry clients in achieving the successful European and US registration of novel drugs for the treatment of ADHD and epilepsy. He has published 150 scientific articles and reviews, given over 350 presentations at international scientific symposia and is a Visiting Professor in the Department of Pharmacy and Pharmacology at the University of Bath.

Dr. Beatrice Setnik, PhD, Vice President, Scientific Affairs, Syneos Health

Dr. Setnik has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. In her previous role as Senior Director, Clinical Sciences (King Pharmaceuticals and Pfizer, Inc.), Dr. Setnik lead the clinical development, regulatory filing, and lifecycle management, including abuse potential evaluation, of several pain compounds including abuse deterrent opioid formulations. In her previous role as a Research Scientist (formerly Ventana / Decisionline Clinical Research, Toronto, Canada), Dr. Setnik was responsible for providing scientific input on various specialty phase I-II clinical trials including abuse potential studies for CNS drugs.

Dr. Setnik has published numerous research articles in internationally recognized peer-reviewed journals and has presented at several scientific meetings and conferences. In addition, she chairs the clinical sub-team within the Cross Company Abuse Liability Council and has been an active member since 2008. Dr. Setnik is also an active member and participant in several congresses including the College on Problems of Drug Dependence. She has also been actively engaged in many aspects of abuse potential assessment including development of patient reported outcome instruments and contributing to post-marketing surveillance studies.

Who Should Attend?

Senior level professionals involved in clinical research or clinical trial data. Relevant job areas include:

  • CNS Clinical Developers
  • Abuse Assessment Program Manager
  • Regulatory Personnel

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