
David Gortler
Fellow
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.
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.
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
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