Dr. David Gortler is a Senior Fellow at The Heritage Foundation. His work focuses on the non-partisan and non-political, clinical and scientific research and evaluation for the advancement and reform of the U.S. Health and Human Services, (HHS) with an emphasis on the U.S. Food and Drug Administration (FDA). Dr. Gortler's areas of expertise include:
- FDA Policy & Reform
- FDA Drug Approval
- FDA Drug Safety
- Research Bioethics
- Elimination of Animal Testing
- Pharmaceutical Supply Chain
- China/India Drug Quality
His work includes technical analysis of various FDA decisions and approvals, and holding FDA and HHS accountable to its mission of improving the health and welfare of Americans. He had previously served as an FDA medical officer/senior medical analyst where he was directly in charge of whether or not to approve new drug applications. He was also in charge of making labeling updates on existing drugs and managing an extensive multi-disciplinary clinical and scientific support team. He 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.
Dr. Gortler is a pharmacologist, pharmacist and a Yale University-trained clinical and molecular biology bench research scientist with a subspecialty in the area of vascular medicine, lipid metabolism and investigational medicine. Following his education and postdoctoral training, he entered the private sector working in drug development for Pfizer. He later returned to the Yale University School of Medicine as a didactic professor of pharmacology and biotechnology. He also served as a faculty representative at Yale’s Center for Bioethics. He left Yale upon being hired by FDA where continued to teach part-time as a professor at the Georgetown University School of Medicine. Dr. Gortler was the first pharmacologist/pharmacist to have been appointed as senior advisor to an FDA commissioner in the FDA’s history.
During his senior executive leadership role at FDA, Dr. Gortler was tasked with reviewing and advising the FDA commissioner on complex clinical and regulatory proposals. He was additionally placed in charge of spearheading major, critical public health initiatives. These included giving consumers transparency on the quality of overseas drug supply, advanced manufacturing techniques, the U.S. on-shoring of critical pharmaceutical manufacturing, overseeing FDA’s list of essential medicines for medical countermeasures, reviewing drug supply chain dynamics, novel medication assisted treatment efforts to address the American opioid crisis and transparency in drug pricing between developers, manufacturers and pharmacy insurance companies.
He advocates for FDA reform, FDA modernization, FDA transparency. He encouraged the use of legacy, inexpensive, generic drug treatments with established and satisfactory safety/efficacy records, as opposed to less established, newer, more expensive treatments with less established safety/effectiveness evidence.
He opposes animal testing and experimentation and is an advocate for advanced human tissue micro-plating technology (“organ-on-a-chip” [OOC] technology) as a potential method of reducing or replacing FDA mandates for animal testing for drug, food and cosmetic approvals. Dr. Gortler’s proposal was widely extolled by scientific thought leaders, including by People for the Ethical Treatment of Animals (PeTA), but FDA career bureaucrats rebuffed and refused to advance his proposals.
He is a board member and technical advisor to the White Coat Waste Project. He is opposed to wasteful NIH taxpayer spending for so-called “curiosity driven experimentation” which has little or no potential to purposefully benefit mankind or advance science.
Dr. Gortler is a licensed Ham Radio operator (KB1PIO). He enjoys vintage automobile rescue, and restoration, and repairing broken things in general. His family has lived in Arizona since the 1940s, having emigrated from Poland.