David Gortler

Fellow

David Gortler, Pharm.D. FCCP, is a Fellow in the Ethics and Public Policy Center’s HHS Accountability Project, where his work focuses on FDA oversight and drug safety. Dr. Gortler is trained as both a pharmacist and a bench-science research pharmacologist, and is an expert in drug and device safety, drug development, the FDA approval process, and assessing drug quality control.

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David Gortler, Pharm.D. FCCP, is a Fellow in the Ethics and Public Policy Center’s HHS Accountability Project, where his work focuses on FDA oversight and drug safety. Dr. Gortler is trained as both a pharmacist and a bench-science research pharmacologist, and is an expert in drug and device safety, drug development, the FDA approval process, and assessing drug quality control.

Prior to joining EPPC, Dr. Gortler worked at the U.S. Food and Drug Administration as a Senior Medical Analyst from 2007-2011, and as a Senior Advisor to the FDA commissioner from 2019-2021. In addition to his public service, Dr. Gortler also has extensive academic experience, having served as an Assistant Professor of Pharmacology at Yale University from 2004-2008 and an Associate Professor of Pharmacology at Georgetown University from 2009-2014. At Yale, he also served as a member of the Yale University Interdisciplinary Center for Bioethics on matters relating to investigational medicine.

During his most recent appointment at the FDA, Dr. Gortler served as a member of the FDA’s Senior Executive Leadership Team advising the Commissioner on device and drug safety (clinical and non-clinical), FDA science policy, and FDA regulatory affairs. As a drug and device safety expert hired to advise the commissioner, Dr. Gortler was also tasked with spearheading major public health initiatives related to the Covid-19 pandemic, one of the FDA’s most critical and scientifically ambitious emergency vaccine and emergency drug authorization challenges in modern public health history.

Dr. Gortler also assisted with strategic scientific support to other members of FDA’s senior leadership team and to advance the commissioner’s policy priorities. These included assuring quality control of overseas drug supply, USA on-shoring of critical pharmaceuticals, major new drug safety implementations, novel Medication Assisted Treatment (MAT) efforts to address the American opioid crisis, transparency in drug pricing, advanced human tissue microplating technology to reduce (or eliminate) animal testing, emergency drug and vaccine development, and urgent Covid-19 regulatory action items to support Operation Warp Speed vaccine development. Dr. Gortler was the first pharmacist/pharmacologist to have ever been appointed as senior advisor to a commissioner in the FDA’s 120-year history.

Dr. Gortler had previously served as an FDA senior medical analyst, and was in charge of approving new drugs and labeling changes within the FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, he was an investigational medicine research scientist and clinical trial principal lead at Pfizer Inc, as well as a scientific and drug safety advisor to Merck & Co, in addition to working for several other major pharmaceutical and medical device developers and manufacturers. Immediately prior to his most recent FDA appointment, he founded the world’s first “analytical pharmacy,” which tested overseas-made drugs from India and China for purity and quality control.

Dr. Gortler also has experience in managing large-scale, critical FDA regulatory projects, as well as supervising scientists and other employees in both the private sector and the federal government. He has formal academic training in both clinical and basic science pharmacology, with a Pharm.D. from the University of Arizona, a postdoctoral basic science research fellowship in vascular medicine/molecular biology from The Yale University School of Medicine, and a clinical residency through The Columbia-New York Presbyterian hospital system.

He also serves as an FDA policy and FDA device and drug safety expert at the boutique consulting group www.FormerFDA.com.

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