David Gortler

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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.

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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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FDA Is Wrong Again: Mailed Abortion Drugs are Not Safe

David Gortler

Mifepristone for chemical abortion is still very hazardous. 

Articles

Brownstone Institute / March 27, 2023

The FDA is Dead Wrong in its Review of Mailed Abortion Pill Safety

David Gortler

You don’t have to read between the lines to figure out the FDA’s mifepristone decision was not clinical or scientific.

Articles

FOX News / February 28, 2023

The FDA’s Paxlovid Pandemonium

David Gortler

Like many other things the Biden White House implements, they force through a multitude of ideas, concepts and public health mandates which “seem” like they could work, but without the requisite conclusive scientifically obtained evidence that they will work.  

Articles

Brownstone Institute / February 27, 2023

Transgenderism’s Scientific Legitimacy Crisis

David Gortler

Humans are born either male or female. No amount of self-perception, self-identification, or “affirmation” can ever change that. 

Articles

The Washington Examiner / January 8, 2023

Omnibus Spending Bill Will Threaten America’s Public Health, on Purpose

David Gortler

To what end is all this independence?

Articles

The Daily Signal / December 21, 2022

Transgenderism interferes with both science and God’s design

David Gortler

“Do not plant your vineyard with two types of seed; if you do, the entire harvest will be defiled — both the crop you plant and the fruit of your vineyard” — Deuteronomy 22:9

Articles

The Christian Post / October 10, 2022

Allowing Biological Males in Women’s Sports is Scientifically Unsound

David Gortler

Surreal progressive colleges, universities, and athletic organizations want to ignore biology and encourage the Kafkaesque.

Articles

Newsweek / October 6, 2022

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