The US leads the world in biomedical innovation, with about 40% of patents being filed by US scientists and companies. The FDA plays a critical role in supporting and enabling this innovation pipeline and our guest Dr. Robert Califf was commissioner of the agency not once, but twice under Presidents Obama and Biden. He joins us to talk about what Americans should know about FDA’s critical role and the threats to its functioning from the dramatic cuts the Trump administration has made over the last three months.

We discuss:

• The broad sweep of FDA’s purview from drugs and medical devices to cosmetics, food, tobacco and dog food
• Concern that the FDA is now “decapitated and eviscerated” from the massive and multiple rounds of dismissals
• While most industries want less regulation, the pharma industry wants more information and guidance from the FDA
• Califf has been affiliated with Duke for 50 of its 100 years, but a part of his heart is still with Clemson

What would Califf’s “Make America Healthy Again” agenda be?

“We need to develop reliable, repetitive sources of information that help people do things that are healthy and beneficial. That part of MAHA I like a lot…The second thing is… I'm developing connections with people who are thinking differently about primary care because I think everybody agrees there's no way you can take the current workforce and deliver what's needed. So it's got to be linked up with AI and digital technologies, but also with a very different looking workforce that gets paid differently, has more respect.”

Relevant Links

• Read Califf’s WSJ opinion letter: “Work with the Bureaucracy, Not Against It”
• Peter Marks’ resignation letter
• NYT article on the impact of FDA layoffs
• Califf’s “Public Health on Call” podcast episode on the state of the FDA
• Opinion article from 7 previous FDA commissioners on how recent changes are undermining credibility of the FDA

About Our Guest

Robert M. Califf, MD served as FDA Commmissioner under Presidents Biden and Obama. Califf is a nationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, and a leader in the growing field of translational research. Prior to rejoining the FDA in 2022, Califf was head of medical strategy and senior advisor at Alphabet, contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. Prior to Alphabet, he was professor of medicine and vice chancellor for clinical and translational research at Duke University, director of the Duke Translational Medicine Institute, and founding director of the Duke Clinical Research Institute. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

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