David Gortler

Fellow

David Gortler, Pharm.D. FCCP, is a Fellow in the Ethics and Public Policy Center’s HHS Accountability Project, where his work focuses on FDA oversight and drug safety. Dr. Gortler is trained as both a pharmacist and a bench-science research pharmacologist, and is an expert in drug and device safety, drug development, the FDA approval process, and assessing drug quality control.

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David Gortler, Pharm.D. FCCP, is a Fellow in the Ethics and Public Policy Center’s HHS Accountability Project, where his work focuses on FDA oversight and drug safety. Dr. Gortler is trained as both a pharmacist and a bench-science research pharmacologist, and is an expert in drug and device safety, drug development, the FDA approval process, and assessing drug quality control.

Prior to joining EPPC, Dr. Gortler worked at the U.S. Food and Drug Administration as a Senior Medical Analyst from 2007-2011, and as a Senior Advisor to the FDA commissioner from 2019-2021. In addition to his public service, Dr. Gortler also has extensive academic experience, having served as an Assistant Professor of Pharmacology at Yale University from 2004-2008 and an Associate Professor of Pharmacology at Georgetown University from 2009-2014. At Yale, he also served as a member of the Yale University Interdisciplinary Center for Bioethics on matters relating to investigational medicine.

During his most recent appointment at the FDA, Dr. Gortler served as a member of the FDA’s Senior Executive Leadership Team advising the Commissioner on device and drug safety (clinical and non-clinical), FDA science policy, and FDA regulatory affairs. As a drug and device safety 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 and emergency drug authorization challenges in modern public health 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. These included assuring quality control of overseas drug supply, USA on-shoring of critical pharmaceuticals, major new drug safety implementations, novel Medication Assisted Treatment (MAT) efforts to address the American opioid crisis, transparency in drug pricing, advanced human tissue microplating technology to reduce (or eliminate) animal testing, emergency drug and vaccine development, and urgent Covid-19 regulatory action items to support Operation Warp Speed vaccine development. Dr. Gortler was the first pharmacist/pharmacologist to have ever been appointed as senior advisor to a commissioner in the FDA’s 120-year history.

Dr. Gortler had previously served as an FDA senior medical analyst, and was in charge of approving new drugs and labeling changes within the FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, he was an investigational medicine research scientist and clinical trial principal lead at Pfizer Inc, as well as a scientific and drug safety advisor to Merck & Co, in addition to working for several other major pharmaceutical and medical device developers and manufacturers. Immediately prior to his most recent FDA appointment, he founded the world’s first “analytical pharmacy,” which tested overseas-made drugs from India and China for purity and quality control.

Dr. Gortler also has experience in managing large-scale, critical FDA regulatory projects, as well as supervising scientists and other employees in both the private sector and the federal government. He has formal academic training in both clinical and basic science pharmacology, with a Pharm.D. from the University of Arizona, a postdoctoral basic science research fellowship in vascular medicine/molecular biology from The Yale University School of Medicine, and a clinical residency through The Columbia-New York Presbyterian hospital system.

He also serves as an FDA policy and FDA device and drug safety expert at the boutique consulting group www.FormerFDA.com.

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The FDA Shouldn’t Cut Corners on Child Vax Safety

David Gortler

An advisory panel adopts a highly casual attitude toward approving a vaccine whose effects on children are unclear.

Articles

National Review Online / October 29, 2021

On Boosters, It’s the White House vs FDA vs CDC vs Fauci vs ‘The Science’

David Gortler

Medicine and health never used to consider politics a relevant data point, but the FDA’s recent silence and back-bending shows this is no longer so. And the FDA is not alone.

Articles

Newsweek / September 29, 2021

White House Mandates Pfizer Vaccines for Millions of Citizens … Before the FDA Clinical or…

David Gortler

Americans are entitled to make informed decisions, and the FDA should disclose its safety and efficacy reviews of Covid-19 vaccines for all to see.

Articles

Forbes / September 15, 2021

How the FDA’s Lack of Transparency Undermines Public Trust

David Gortler

As the arbiters of drug safety and efficacy, we all entrust the FDA to conduct comprehensive reviews of data. In turn, the FDA ought to embrace the public’s legitimate concern and welcome scientific discussion regarding its decisions.

Articles

Forbes / August 24, 2021

Unforgivable Hypocrisy From FDA’s Career CDER Leadership

David Gortler

The same career FDA bureaucrat who loudly crowed about “following the science” to discredit President Trump has approved a failed Alzheimer’s drug.

Articles

Forbes / July 19, 2021

FDA’s New CDER Director Grants Approval of Yet Another Expensive, Scientifically Questionable Drug … More…

David Gortler

Since the FDA operates without external oversight, it’s not possible to hold the agency accountable for bad approval decisions that ultimately place taxpayers on the hook for hundreds of billions of dollars via Medicare Part B program.

Articles

Forbes / June 11, 2021

Drug Quality “Trumps” Drug Pricing

David Gortler

There is an enormous national security risk to relying on geopolitical adversaries like China for America’s life-saving drugs. This is similar to the risk that both the Republican and Democrat parties recognized with respect to our energy supplies, where a renewed focus on domestic production enabled the U.S. to become a net oil exporter by 2019. The move to energy independence created good paying jobs for thousands of Americans.

Articles

Forbes / May 25, 2021

China Is at War with the FDA. Guess Who’s Winning.

David Gortler

China is allowing only those tested for COVID-19 and vaccinated with its proprietary vaccines to enter their country. This represents a problem when it comes to the regulation of drugs for American consumers: China’s vaccine entry requirements make it nearly impossible for the FDA to fully staff regulatory operational activity in China.  

Articles

Forbes / April 23, 2021

The FDA Under Biden – Here’s How Drug Safety, Public Health Issues Are Being Compromised

David Gortler

The Biden administration’s instant political dismissal of key public health and FDA safety programs, without any reasonable transition, not only dissolved great ideas and threw away decades of expertise and insight – it wasted taxpayer money.

Articles

Fox News / March 20, 2021