David Gortler

Fellow

David Gortler, Pharm.D. FCCP is a Fellow at the Ethics and Public Policy Center whose work focuses on FDA oversight and accountability. Dr. Gortler is a pharmacologist and pharmacist and a Yale-trained bench research scientist in molecular biology with a subspecialty in the field of vascular medicine.  He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Center for Bioethics, and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner.

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David Gortler, Pharm.D. FCCP is a Fellow at the Ethics and Public Policy Center whose work focuses on FDA oversight and accountability. Dr. Gortler is a pharmacologist and pharmacist and a Yale-trained bench research scientist in molecular biology with a subspecialty in the field of vascular medicine.  He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Center for Bioethics, and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner.

His is the only “think tank” position of its kind overseeing the FDA’s 18,000 regulatory and scientific employees and its $6.5 billion dollar budget, $3.6 billion of which was discretionary spending (as of 2022).  Overall, the FDA regulates more than $2.4 trillion worth of consumer goods, much of these expenditures are for goods imported into the United States.

Prior to joining EPPC, Dr. Gortler worked at the U.S. Food and Drug Administration as a medical officer/senior medical analyst from 2007-2011.  He was later appointed as senior advisor to the FDA commissioner on drug safety and FDA policy from 2019-2021.  Between his positions with the FDA he worked clinically and taught at the Georgetown University School of Medicine as an associate professor.  He also advised and advocated for FDA reform and “freedom to choose medicine” policy at the libertarian/conservative Heartland Institute.

Dr. Gortler founded the world’s first “analytical pharmacy,” which tested overseas-made drugs from India and China for purity and quality control and served as the editor-in-chief and on the editorial board of multiple specialty journals covering investigational medicine.

Dr. Gortler is a published scientist whose work specializes in: 1) clinical and non-clinical drug safety, 2) data collection/assessments through the FDA’s AERS database, 3) vaccine safety data collection/assessments through the FDA’s VAERS database, 4) device safety data collection/assessments through the FDA’s MAUDE database, 5) clinical trial design, 6) speeding up the FDA approval process, and 7) drug quality control.  He is a regular columnist at Forbes.com on these subjects.

Prior to his public health service, Dr. Gortler was a didactic Assistant Professor of Pharmacology at Yale University School of Medicine from 2004-2008 and an Associate Professor of Pharmacology at Georgetown University from 2009-2014.  At Yale, he also served as a faculty member on the Yale University Interdisciplinary Center for Bioethics on matters relating to ethics in investigational medicine.

During his most recent appointment, he served on the FDA’s Senior Executive Leadership Team where he was senior advisor to the FDA commissioner on device and drug safety (clinical and non-clinical), FDA science policy, and FDA regulatory affairs.  As a drug and device safety subject matter 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 authorization challenges in modern public health history.  Dr. Gortler was the first pharmacist/pharmacologist to have ever been appointed as senior advisor to an FDA commissioner in the FDA’s 120+ year 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 through career FDA staff. These included assuring quality control of overseas drug supply, the U.S. on-shoring of critical pharmaceuticals, drug supply chain dynamics, novel Medication Assisted Treatment efforts to address the American opioid crisis, transparency in drug pricing and advanced human tissue micro-plating technology (A/K/A “organ-on-a-chip” technology).

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QUOTED: Dr. David Gortler on FDA Panel Recommendation of Moderna Vaccine for Children

June 14, 2022 | Children’s Health Defense

On June 14, 2022, EPPC Fellow Dr. David Gortler was quoted by Children’s Health Defense’s publication The Defender on the…

INTERVIEW: Dr. David Gortler on How FDA’s Cavazzoni Ignores Science And Refuses To Stop Animal Cruelty

March 15, 2022 | Principia Scientific International

This interview with EPPC Fellow Dr. David Gortler was published by Principia Scientific International. When a former Yale University professor…

QUOTED: David Gortler on the Loss of Trust in Public Health Agencies

March 2, 2022 | The Christian Science Monitor

On March 2, 2022, EPPC Fellow Dr. David Gortler, a former senior advisor to the FDA Commissioner, was quoted in…