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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Biological Gender is Crucial to Medical Practice

David Gortler

EPPC Fellow David Gortler compiled a list of over 100 medical formulas which require the specification of biological gender. The…

Articles

Medical Formulas Based on Sex Support Biology as the Basis for Gender

David Gortler

In all, definitive gender-related metabolism is a critical consideration in establishing doses for some of the most common drugs in every major classification.

Articles

FDA, White House Ignoring Science By Touting Ineffective Pfizer COVID Vaccines and Pfizer’s “Rebounding” Paxlovid

David Gortler

Is there some sort of unholy union between the FDA, Pfizer, and the Biden White House?

Articles

The Federalist / August 4, 2022

The FDA Has Lost its Soul

David Gortler

Under Biden, every single bad decision at the FDA has been addressed with spin, closed ranks, finger-pointing, excuses, obfuscation, withholding of documents, and accusing critics of race-based motives. 

Articles

The New American / August 2, 2022

FDA Approval Of Over-The-Counter Birth Control Puts Women’s Health At Risk

David Gortler

Should oral contraceptives be obtained without a prescription from a medical provider, a number of critical assessments will be overlooked.

Articles

The Federalist / July 26, 2022

Biden’s FDA Supports Vaccinating America’s Infants While his CDC Selectively Ignores Risks From Illegal Immigrants

David Gortler

While the FDA pushes vaccines on all age groups—claiming that a dire COVID-19 public health emergency still exists—the White House appears perfectly comfortable with the CDC’s April 1 decision to terminate a public health authority meant to prevent the spread of COVID-19 across our borders.

Articles

Newsweek / July 15, 2022

How the White House’s New FDA Commissioner Caused the Baby Formula Crisis

David Gortler

The FDA’s current way of doing things is badly outdated and has proven to be politically unworkable, unreliable, and unsafe.

Articles

The Pharmacy Times / July 13, 2022

Joe Biden’s COVID Vaccine Strategy: Shots For Kids, But Not Illegal Immigrants

David Gortler

Under President Biden, our own federal agencies don’t agree if we are in a health emergency or not.

Articles

1945 / June 30, 2022

Why are FDA Employees Still Working From Home While Pushing “Safe and Effective” COVID-19 Vaccine…

David Gortler

If the COVID-19 vaccines really were safe and effective, you would think the FDA employees would have already returned to work, setting an example for employees all over the country.

Articles

American Thinker / June 28, 2022

Biden Pays Big Bucks for Pfizer’s Latest Flop

David Gortler

The Biden administration is paying $10.6 billion in taxpayer money for Pfizer’s unoriginal and ineffective Covid-19 drug, Paxlovid.

Articles

The American Conservative / June 28, 2022

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