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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FDA Botches Updates to Prescription Authorization System, Leaving Vulnerable Americans Without Critical Medication

David Gortler

The Biden administration is not filled with “follow the science” technocrats, but anti-science, ideological busybodies starting at the top.

Articles

The Daily Signal / January 10, 2022

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