Abraham Hartzema, Pharm.D., MSPH, Ph.D., FISPE

Abraham G. Hartzema is Professor and Eminent Scholar Emeritus at the University of Florida in the Department of Pharmaceutical Outcomes & Policy. He occupied the Perry A. Foote Chair in Health Outcomes Research, and Professor in Epidemiology and Biostatistics in the College of Public Health and the College of Medicine. In the year 2007, he was awarded the University of Florida Foundation Research award.

Dr. Hartzema has widely published on various aspects of prescription drug safety, including several books on Pharmacoepidemiology. Entitled “Pharmacoepidemiology and Therapeutic Risk Management” was published by Harvey Whitney Book Publishers. Co-edited with Hugh Tilson (UNC-Chapel Hill) and Arnold Chan (Harvard University) the book reflects the new therapeutic risk management paradigm as implemented by the US FDA. Most recently Ayad K. Ali and Abraham G Hartzema co-edited Post-Authorization Studies of Medicinal Products, or the PASS book published by Elsevier Academic Press, 2018.

He has served on the scientific board of the FIP from 1988-1996; and on editorial boards, including Medical Care, Annals of Pharmacotherapy, Clinical Therapeutics, the International Journal of Pharmacy Practice, Pulmonary Circulation and others. In 2003 he was bestowed fellow status in the International Society on Pharmacoepidemiology. He has been the Chair of Data Safety and Monitoring Boards. He has also served on the University of Florida Graduate Council, and grant review panels for AHRQ, FDA, HealthCanada, DSEN, NASA, NIH, and NIHBL. He currently serves on the United States Pharmacopeia: Nomenclature, Safety and Labeling Expert Committee. He was recently appointed as Senior Advisor to the FDA, Center for Devices and Radiological Health.

Dr. Hartzema’s research funded by the Agency for Healthcare Research and Quality, NIH, the FDA, the Florida Office of Rural Health and several pharmaceutical companies. His recent study (2020-2022) on preventing opioid misuse is funded by the NIH/NIDA. Theoretical interests are in data mining techniques, developing metrics for the benefit/risk ratio of drugs, methods development for active medical product safety surveillance, and bias calibration in observational methods.

Dr. Hartzema was on faculty leave (2008–2009) in the US Food and Drug Administration’s Immediate Office of the Commissioner working on the Congressional mandated Sentinel Initiative. He also served as a Principle Investigator on the Observational Medical Outcomes Partnership (OMOP), a public-private partnership between the US-FDA, the Foundation of the National Institute of Health and PhRMA. He is currently Chief Scientific Officer of SureMed Compliance LLC.

Health outcomes research with an emphasis on: Pharmacoepidemiology, Active Drug Safety, Surveillance methods development, Therapeutic risk management and Program evaluation