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David Gortler

Contact David Gortler

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Dr. David Gortler is a professor of pharmacology and biotechnology and former White House appointee who served as Senior Advisor to the FDA Commissioner and the HHS/FDA Senior Executive Leadership Team.

David Gortler, Pharm.D., FCCP, is a recognized expert in device and drug safety, FDA policy and FDA regulatory affairs. He is the Heartland Institute’s senior policy advisor focusing on FDA policy and healthcare policy. 

He is trained as both a pharmacist, pharmacologist and bench scientist and has over 20 years of experience in drug development including over 15 years of experience in pedagogy as a didactic professor of clinical and non-clinical pharmacology.  Dr. Gortler is an expert on evaluating safety and efficacy and the laws, regulations and rules of the United States FDA.  Dr. Gortler has authored or co-authored over 60 scientific publications, papers, articles, reviews, clinical protocols and reports. 

Dr. Gortler has been interviewed and/or quoted over 100 times by news reporters working for both major newspapers and magazines/periodicals, as well as by specialty news publications, as an authority in his areas of expertise.  Dr. Gortler has also been invited to testify in front of the United States Senate and an expert on matters relating to FDA policy, regulatory affairs and drug safety. 

He has served as the healthcare/ FDA regulatory affairs and FDA policy advisor to both a United States president and a United States presidential candidate.  He has served at the FDA under a total of three consecutive United States presidential administrations. 

Dr. Gortler was an Assistant Professor of pharmacology at The Yale University School of Medicine.  At Yale, he taught graduate level clinical pharmacology and FDA regulatory affairs courses to medical students and Ph.D. candidates.  He also was involved in multiple interdisciplinary scientific and research collaborations and made multiple academic presentations to the faculty.  He also served as a faculty member of the Yale University Center for Bioethics, clinical trial ethics working group and the research ethics writing group. 

During his first tour of duty at the FDA, he served at the FDA as a medical officer/senior medical analyst in the office of new drugs.  He was the lead clinical reviewer responsible for the evaluation the safety and efficacy analyses of clinical study proposals, reports, product labeling, new drug applications, new protocols and protocol amendments.  Dr. Gortler was personally in charge of approving new drugs and revising the FDA labeling of existing drugs based on the most recent clinical and scientific findings. 

During his second tour of duty at the FDA, he served on the FDA senior executive leadership team as senior advisor to the FDA commissioner.  As part of his duties, he advised the FDA Commissioner and other members of the FDA senior executive leadership team on scientific matters which included drug and device safety, FDA policy and FDA regulatory affairs. 

Dr. Gortler's appointment was made during the early stages of 2019-nCoV pandemic.  The 2019-nCoV pandemic, now viewed as the FDA’s most critical and scientifically ambitious emergency vaccine and emergency drug authorization approval challenges in modern public health history. 

In advancing FDA policy, Dr. Gortler worked directly at the White House, updating and advising senior White House departmental directors, White House counsel, presidential special assistants and presidential advisors on the latest, state-of-the-art recommendations to improve public health, FDA safety monitoring, assuring supply chain quality and integrity, and accelerate novel drug development. 

He currently serves as an FDA subject matter expert at www.FormerFDA.com and The Heartland Institute where he gives policy guidance on the FDA’s thought process by which new drugs are evaluated and become approved for marketing in the United States through the FDA.  

Supplemental Links:

David Gortler cv on Leadership Connect

David Gortler editorial bio on JDRAD

David Gortler aggregate publication profile on Muckrack

David Gortler on google scholar

David Gortler Scientific American

David Gortler WIRED FDA op-ed

David Gortler Boston Globe FDA op-ed

David Gortler Bloomberg News FDA op-ed

David Gortler Federalist

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Recent Articles and Publications

view all by this author
April 2, 2020
By David Gortler
America is completely dependent on China and India for its pharmaceutical drug supply.
March 24, 2020
By David Gortler
America is objectively dependent on China and India for its drug supply. COVID-19 is expected to dry up this supply.

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