David Gortler

David Gortler, Pharm.D. FCCP is a Scholar at the Ethics and Public Policy Center whose work focuses on the non-partisan and non-political, scientific and technical oversight and accountability of the U.S. Health and Human Services, (HHS) with an emphasis on oversight and accountability of the U.S. Food and Drug Administration (FDA) as a means to advance and improve America’s public health.

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). His oversight includes oversight of the FDA’s more than $2.4 trillion worth of consumer goods, or about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods imported into the United States which can be a problem form a safety and quality control standpoint. The FDA is responsible for monitoring of FDA regulated products for safety and quality control, but only rarely does its own independent verification testing of imported Chinese and Indian pharmaceuticals for qualitative and quantitative assessments.

Immediately prior to his most recent FDA appointment, he also personally conceptualized and founded the world’s first “analytical pharmacy” which tested overseas-made drugs from India and China for purity and quality control. His analytical laboratory published findings which the FDA independently confirmed which then then lead to multiple drug recalls for multiple popular prescription medications with cancer-causing chemical impurities, which would otherwise have been prescribed to American patients indefinitely.

During his most recent FDA appointment, Dr. Gortler was also tasked with spearheading major public health initiatives, including those related to the COVID-19 pandemic. Dr. Gortler assisted with strategic scientific support to other members of FDA’s senior leadership team and to advance the commissioner’s policy priorities via career FDA staff. These included assuring quality control of overseas drug supply, the U.S. on-shoring of critical pharmaceuticals, composing the FDA’s list of essential medicines for medical countermeasures, 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” [OOC] technology) as a proposed methodology to eliminate the need for tens of millions of animals killed each year, in decades-outdated testing requirements still mandated by the FDA. His research and advocacy in proposing OOC use in preclinical drug trials, would have eliminated the use of primates, beagles, rabbits, rats, mice and other animals was widely lauded by many, including by People for the Ethical Treatment of Animals (PeTA) but ultimately and unilaterally rejected by FDA career officials for reasons which are still unclear.

Dr. Gortler is a pharmacologist, pharmacist and a Yale University-trained bench research scientist in molecular biology with a subspecialty in the field of vascular medicine and lipid metabolism. Following his education and training, he entered the private sector working as an early and middle phase investigational medicine research scientist for Pfizer. He was later hired as professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served as a faculty member of the Yale’s Center for Bioethics. He left Yale University’s faculty when he was brought on to the FDA where he became a medical officer/senior medical analyst who was later appointed to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner for drug safety and FDA science policy.

He has authored over 100 papers, articles, reviews, protocols, reports and editorials on the topics of drug development, drug safety, science policy and pharmacology and is an advocate for FDA reform and “Freedom to Choose Medicine.” Dr. Gortler was the first pharmacologist pharmacist to have ever been appointed as senior advisor to an FDA commissioner in the FDA’s 120+ year history.

He also served as the editor-in-chief and/or on the editorial boards of multiple peer-reviewed specialty academic journals covering investigational medicine, pharmacology and biotechnology.

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