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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Hold Federal Health Officials Accountable for Misleading Us

David Gortler

No scientific accountability will ever take place under existing government leadership.

Articles

Heartland Daily News / April 10, 2022

Vaccine Malpractice

David Gortler

Government pharmacists, physicians, and nurses have violated their oaths and obligations to protect patient safety.

Articles

Claremont Institute / March 30, 2022

FDA, CDC Guilty of Clinical Malpractice and Scientific Fraud by Inaction and Omission on mRNA…

David Gortler

These outrageously political, manipulative, science-ignoring federal officials must be held accountable.

Articles

American Thinker / March 29, 2022

Why Aren’t The FDA And CDC Informing The Public About Documented Adverse Events After mRNA…

David Gortler

DA and CDC pharmacists, physicians and nurses have violated sacrosanct ethical and academic oaths and state licensure obligations to protect their patients by not fully disclosing updated efficacy and safety data on COVID vaccines.

Articles

The Federalist / March 25, 2022

CDC Tells New York Times It Hid Covid Data For Political Reasons

David Gortler

Selectively cherry-picking ‘The Science’ to suit a political narrative is not ‘Following the Science.’ It is malpractice and fraud.

Articles

The Federalist / March 22, 2022

FDA Rushes to Grant EUAs to Two More COVID Drugs With No Long-Term Safety or…

David Gortler

With epidemiological findings in on vaccination and boosters verified from around the world, it only makes sense to consider other available treatment strategies.

Articles

PJ Media / February 14, 2022

Former Senior FDA Official: Manufacturers, FDA Negligent In Not Investigating Covid-19 Vaccine Risks To Heart…

David Gortler

Manufacturers, FDA, and CDC must investigate serious cardiovascular incidents related to the Pfizer and Moderna Covid vaccines.

Articles

The Federalist / February 10, 2022

How Biden-Harris Ignored Science, Politicized COVID-19 Boosters, and Misinformed the World

David Gortler

COVID case numbers from December suggest vaccines and boosters did little if anything to slow the spread of Omicron. Despite these findings, the president has continued to scold and belittle Americans who have chosen not to take a vaccine or booster in recent weeks.

Articles

Newsweek / January 26, 2022

EPPC Scholars Submit Public Comment Opposing OSHA’s Unlawful Vaccine Mandate

Roger Severino

EPPC scholars Roger Severino, Rachel N. Morrison, Dr. David Gortler, and Dr. Aaron Kheriaty submitted a public comment opposing finalization of OSHA’s rule that would mandate COVID-19 vaccination in workplaces.

Articles

Publications / January 20, 2022

COVID Boosters for Omicron Are Not ‘Highly Effective’ and Americans Are Not ‘Highly Protected’

David Gortler

The Covid-19 virus will be with us for decades, just as the flu has persisted despite the availability of vaccines.

Articles

American Thinker / January 19, 2022

Vaccine Manufacturers, FDA Not Adequately Warning About Myocarditis Risks

David Gortler

The FDA’s VAERS database shows a long and impersonal number of cardiovascular-related events in young healthy people.

Articles

American Thinker / January 19, 2022

Moral Progress Denied By FDA Leadership: New ‘OOC’ Technology Could Have Allowed The FDA To…

David Gortler

Despite decades of limited gains from animal testing of drugs meant for humans, FDA leadership continues to block and ignore state-of-the-art alternatives that would likely end outdated and cruel animal testing and speed up investigational drug development.

Articles

Forbes / January 11, 2022