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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Evidence Shows Healthy Children Don’t Need COVID-19 Vaccines

David Gortler

There is no need for a primary series of COVID-19 vaccines for children. The young have a decreased benefit from COVID-19 vaccination but are also at a greater safety risk. Plus, many children have already had COVID and have the benefits of naturally acquired immunity.

Articles

Charlemagne Institute / June 15, 2022

FDA Pushes To Authorize Novavax’s Covid-19 Vaccine Despite Serious Cardiovascular Safety Issues

David Gortler

The FDA appears to have lost its high standard for drug safety and efficacy, and it is the American public who will suffer.

Articles

The Federalist / June 9, 2022

EPPC Scholar Submits Public Comment Opposing EUAs for Pfizer, Moderna Covid Vaccines for Children

David Gortler

EPPC Fellow David Gortler submitted a comment to the FDA for a public advisory meeting of the Vaccines and Related Biological Products Advisory Committee opposing Emergency Use Authorization requests by Moderna and Pfizer for Covid vaccines for children.

Articles

 

EPPC Scholar Submits Public Comment Objecting to Novavax Vaccine EUA

David Gortler

EPPC Fellow David Gortler submitted a public comment to the Food and Drug Administration on a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older.

Articles

 

The FDA Commissioner’s Embarrassing Lecture on ‘Misinformation’

David Gortler

America’s top FDA official uses his appointed pulpit to make sweeping claims about public health without a single iota of evidence, while ignoring information which could actually benefit Americans.

Articles

Claremont Institute / June 6, 2022

The “Biden Adults” Are in Charge. . . But Americans Still Can’t Get Baby Formula

David Gortler

Although the Biden administration likes to repeat that they are the “adults” back in charge, they regularly attempt to cover up their many failures by blaming others.

Articles

The Federalist / May 27, 2022

How Biden’s FDA Helped Cause the Baby-Formula Crisis

David Gortler

The FDA’s current way of operating is badly outdated, politically unworkable, unreliable, and unsafe.

Articles

National Review Online / May 24, 2022

HHS Guidance on Trans Pharmacology Raises More Questions Than It Answers

David Gortler

Observant scientists and clinicians will notice the document is most remarkable for what it doesn’t say.

Articles

Newsweek / May 19, 2022

Sin, Original Sin, Original Antigenic Sin and COVID-19 Natural Immunity

David Gortler

While being secretive and non-transparent about vaccine data but simultaneously accusing Americans for not “following the science,” the NIH, CDC, FDA and Biden administration ignored medical science.

Articles

The Christian Post / May 2, 2022

EPPC Scholars Explain to HHS How Federal Government Promoted COVID-19 Health Misinformation

Rachel N. Morrison

EPPC HHS Accountability Project Fellows Dr. David Gortler and Rachel N. Morrison submitted comment in response to a request for information by the Department of Health and Human Services on the impact and prevalence of “health misinformation” during the COVID-19 pandemic.

Articles

 

America’s Reliance on China for Pharmaceuticals Could Result in Ukraine-Like Drug Shortages

David Gortler

Americans who think that critical drug-supply shortages could never happen here should think again.

Articles

Issues & Insights / April 12, 2022

If Monoclonal Antibody EUAs Are Being Revoked, Shouldn’t COVID Vaccine Approvals Be as Well?

David Gortler

The FDA has finally admitted that its approved monoclonal antibody treatments no longer work and is pulling them off the market. Yet the White House and the FDA stubbornly cling to their narrative on vaccines.

Articles

PJ Media / April 11, 2022