Yale’s Senior Advisor to the FDA Commissioner

David Gortler, PharmD, was four years into teaching pharmacology at Yale School of Medicine (YSM) when he was first approached by the U.S. Food and Drug Administration (FDA). Officials from the agency invited him to present his research in Washington, D.C. It wasn’t long before he was on the FDA’s staff as a medical officer evaluating new drugs for approval.

Gortler recently completed a second tour on the FDA’s executive leadership team as the first and only pharmacist/pharmacologist ever appointed senior advisor to the FDA commissioner. He served as an expert in drug safety, FDA regulatory affairs, and science policy. “It was a dynamic and high-pressure role, especially as we helped see through the emergency authorization of two novel mRNA vaccines to treat COVID-19,” Gortler said.

Gortler was also part of the leadership team at the FDA that identified essential medicine, medical countermeasures, and critical inputs to serve patient needs in the event of another public health emergency. He was valued there chiefly for his expertise and advocacy concerning the return of medication production to U.S. soil from overseas; and a strong commitment to rigorous quality assurance and quality control (QA/QC) of the international medical equipment and pharmaceutical supply chain.

“QA/QC is a very serious concern,” said Gortler. “We spend billions of dollars and years evaluating clinical data to make sure drugs are safe to take. In the end, third-party insurance companies called PBMs (pharmacy benefit managers) require patients to take tablets from the cheapest manufacturer possible. Unfortunately, many of these tablets are of questionable quality. In the U.S. and Europe, the FDA can walk in at any time to a drug manufacturing facility to inspect them. In China and several other countries, you can’t. Frequent and unannounced inspections are a vital part of the FDA’s mission.”

Passionate about the issue and concerned for the overall health of Americans, Gortler personally conceptualized and helped found Valisure, the world’s first analytical pharmacy, in 2015. The goal is to ensure that any drug produced globally is labeled accurately with regard to milligram strength and without toxic adulteration. That analytical pharmacy was instrumental in having the drugs ranitidine (Zantac) and valsartan (Diovan) pulled from shelves around the world.

“There’s no way for consumers, pharmacists, or physicians to know whether what is stated on every bottle at your pharmacy or hospital is accurate. Unlike the U.S., if an inspector goes to China or India and an inspection is refused, the FDA just issues an obscure note on its Import Alerts website because it has no Congressional recall authority. Import alerts don’t affect the pills already in the U.S.,” said Gortler.

Gortler has been focused on protecting the population through pharmacology since a very young age. He studied chemistry as an undergraduate; pharmacy and pharmacology as a graduate student; and later completed a residency at Columbia before moving on to a specialty residency and postdoctoral fellowship in molecular biology and a subspecialty in vascular medicine and arteriosclerosis at YSM.

His investigational medicine research and drug safety career continued at Pfizer, where he designed, composed, and supervised a team of scientists covering the first in-human and early-phase investigational medicine clinical trials. It was during that time that he was offered the chance to return to Yale as an assistant professor before being recruited later for his first position with the FDA.

While at the FDA, Gortler also advocated for reducing or eliminating the FDA’s requirements for animal testing in favor of brand-new state-of-the-art OOC (human organ-on-a-chip technology, which uses microchips lined with living human cells to model human disease states). “In addition to reducing harm to animals—a regrettable longtime necessity for scientific progress—this device stands to greatly speed up drug development and approval. It’s a win on both sides,” he said.

Gortler recently accepted a position as senior scholar with the Ethics and Public Policy Center (EPPC) think tank in Washington, D.C. He believes that there is a lot more work needed to modernize FDA policy in regard to speeding up drug discovery, approval, quality control, preclinical testing, drug safety, and adverse event reporting.

He fondly recalls his Yale education and professorship appointment, and is grateful to many faculty and colleagues for helping shape his moral compass, and for putting him in the best possible position to continue working to improve public health.