Regulatory/FDA

Here’s the 411 on FDA Commissioner Nominee Martin Makary, MD, MPH

Martin (Marty) Makary, MD, MPH is a gastro-intestinal/pancreas surgeon and public policy researcher at Johns Hopkins University. He is  a prolific author, writing for The Washington Post and The Wall Street Journal, authoring of three New York Times bestselling books – UnaccountableThe Price We Pay and Blind Spots – and regularly commentating on CNN and Fox News.

Dr. Makary is an excellent communicator with strong, often persuasive and articulate science-based views on many healthcare issues.  If confirmed by the U.S. Senate, he will have a powerful platform to express these views and public communications as FDA Commissioner.

Background

Clinically, Dr. Makary is the chief of Islet Transplant Surgery at Johns Hopkins. He is the recipient of the Nobility in Science Award from the National Pancreas Foundation and has been a visiting professor at over 25 medical schools. According to his official biography, he has published over 250 peer-reviewed scientific articles and has served on several editorial boards. Dr. Makary served in leadership at the World Health Organization Patient Safety Program and has been elected to the National Academy of Medicine.

Dr. Makary also serves as a professor at the Johns Hopkins School of Medicine and a professor, by courtesy, at the Johns Hopkins Carey Business School. His current research focuses on the underlying causes of disease, public policy, health care costs, and relationship-based medicine.

Dr. Makary served from 2020-22 as MedPage Today’s Editor-in-Chief for their Editorial Board.  He also currently serves as chief medical adviser to Nava, a benefits brokerage, and chief medical officer at Sesame, a telehealth company that offers compounded weight loss drugs. Novo Nordisk and Eli Lilly, the makers of blockbuster drugs Ozempic and Zepbound, respectively, havclashed with compounding pharmacies that make more affordable copycat versions of the drugs. The drugmakers have been publicly urging the FDA to classify the drugs as too complex to safely compound.

Dr. Makary was born in Liverpool, England, and moved to Baltimore as a young child. His family later moved to Danville, PA, where his father (Dr. Adel Makary) works as a hematologist at Danville’s Geisinger Medical Center. Makary graduated with a B.S. from Bucknell University, a Master of Public Health from Harvard University, medical degree from Thomas Jefferson University, along with surgical residency training at Georgetown University, as well as sub-specialty training in surgical oncology and gastrointestinal surgery at Johns Hopkins Hospital.

While Dr. Makary positions himself as a medical system disrupter, he does have a strong reputation for being scientific evidence based and an incrementalist when it comes to changes needed in the healthcare system.

For more on Dr. Makary’s views about the U.S. healthcare system and microbiome (or food as medicine), please watch the podcast interview on “What Modern Medicine Gets Wrong” with Russ Robert’s Econ Talk in August. His views appear to be based on the theme that medical system decisions are often currently built on financial incentives and traditional practices, more than based on science, requiring disruption in order to provide better care.

Potential Impact on Healthcare Marketing

Dr. Makary does not appear to have taken strong views publicly or in his books on the FDA, beyond criticism of how it handled opioid approvals, focusing more on how the medical establishment manages health matters rather than on product decisions made by the agency.

He also does not appear to have taken any position on direct-to-consumer (DTC) television advertising.  It doesn’t mean that President Trump or his HHS Secretary would not try to pressure the new FDA commissioner (as done during his previous term to approve hydroxychloroquine as a COVID treatment) into putting forward rules to limit or ban new drug advertising. However, further restrictions beyond the current FDA DTC prescription drug advertising rules that became enforceable in November would likely require new legislation. With the Supreme Court’s ruling this summer overturing the Chevron doctrine that allowed agencies some deference in their rulemaking, federal agencies will now face legal challenges on regulations that are not squarely authorized by Congress.

In addition, the FDA’s new commissioner will face several challenging issues, such as how to use and regulate AI in healthcare, FDA’s $7.2 billion budget employing 18,000 people and responsible for regulating the nation’s drug, medical device and food supply, and how to improve biosimilar and generic drugs approvals, as well as how to manage court decisions that overrule FDA scientific decisions without the Chevron doctrine in place.

If confirmed, Dr. Makary would be the third physician nominated by President Trump who had two FDA commissioners during his first term – Drs. Scott Gottlieb and Stephen Hahn.