Dr. David Gortler is a Senior Research Fellow where his work focuses on the clinical and scientific evaluation of US healthcare and medical policy, with an emphasis on reform, modernization, decision transparency, and accountability of the US Food and Drug Administration (FDA). His areas of expertise include FDA regulatory policy, drug approval and safety, clinical trial evaluation methodologies, pharmaceutical quality, global supply chains, and research ethics. 

Dr. Gortler previously served as an FDA Medical Officer/Senior Medical Analyst, where he was the lead for reviewing, evaluating and making approval or rejection recommendations for Investigational New Drugs (INDs), New Drug Applications (NDAs), product labeling and post-market safety analyses of novel and established drugs after comprehensively examining clinical trial data. He worked closely with multidisciplinary scientific and regulatory teams—both internal at the FDA and external in pharma—to ensure compliance with statutory and regulatory standards.

He was later appointed to the FDA’s Senior Executive Leadership Team as Senior Advisor to the FDA Commissioner on drug safety, regulatory policy, and FDA science policy initiatives. He simultaneously served as an expert for senior White House advisors and staffers on critical, complex, and high-stakes regulatory public health matters related to a wide variety of FDA regulations and obligations.

During his tenures at the FDA, Dr. Gortler was involved in the review of complex clinical and regulatory proposals and worked with career employees to contribute to guidance documents and major public health and policy proposals. His writing addressed pharmaceutical supply chain vulnerabilities, including risks associated with America’s reliance on foreign drug manufacturing, pharmaceutical precursor manufacturing, essential medicines, and a broad array of both clinical and non-clinical drug safety topics. He also advanced policies aimed at strengthening and expanding domestic pharmaceutical production, state-of-the-art manufacturing technologies, and emphasizing the need for increased oversight of drug quality and safety.

His writings include more than 200 published articles, in addition to investigational medicine protocols, reviews, study reports, and clinical trial designs. Several landmark publications have been widely cited, translated, and continue to be relied upon by FDA personnel as well as medical policymakers around the globe. He has testified as an FDA and drug safety expert in front of Congress and congressional panels on several occasions. 

In addition to his federal service, Dr. Gortler has extensive experience in both academia and industry. He began his career in commercial pharmaceutical development where he designed and supervised investigational medicine administration. He was later appointed as professor of pharmacology and biotechnology at the Yale University School of Medicine, where he taught graduate-level coursework and conducted research in vascular biology, heart disease, and lipid metabolism. He was appointed as the Yale pharmacology department’s representative to Yale’s Center for Bioethics where he proposed standards for clinical trial and research bioethics. He subsequently taught medical students at the Georgetown University School of Medicine while serving in government.

Dr. Gortler’s research and healthcare policy work emphasize regulatory accountability, scientific rigor, and the modernization of what the FDA does. He has written extensively on drug safety, and the need for greater transparency in FDA decision-making. He is a long-standing advocate for eliminating animal testing in favor of advancing human tissue–based technologies such as organ-on-a-chip systems, as part of a broader effort to improve the scientific validity, efficiency, and speed of preclinical research. His proposals have been widely praised by scientific, medical, ethics, and public policy leaders, and included the People for the Ethical Treatment of Animals (PeTA). 

He is a board member and technical advisor to the White Coat Waste Project and has contributed to policy discussions on federal research priorities and the responsible use of taxpayer funding in biomedical research.