Robert Califf
Two-Time FDA Commissioner | Professor, Duke University School of Medicine
Robert Califf, MD, led the FDA through two administrations, first in 2016 and again from 2022 to 2025, when the White House called him back in the middle of the Omicron wave. A cardiologist by training, he founded the Duke Clinical Research Institute in 1996 and helped pioneer thrombolytic treatment for heart attacks at a time when, in his words, the standard of care was prayer, morphine, and nitrates.
Between his two terms at the agency, he served as Head of Clinical Policy and Strategy at Verily and Google Health under Alphabet. One of the most cited medical researchers in the world, with more than 1,300 peer-reviewed publications, he now teaches at Duke University School of Medicine and works across healthcare delivery and medical product development.
Califf appeared on Open Door Salon alongside Vid Desai, the FDA’s first Chief Information Officer, for a conversation with host Lori Ellis about what leadership turnover is doing to the agency. He described the loss of institutional knowledge as calamitous, distinguished the policy-setting role of a commissioner from the impartial refereeing done by career civil servants, and argued that any American strategy built on walling the country off from Chinese biotechnology is doomed to fail.
Frequently Asked Questions About Robert Califf
Who is Robert Califf?
Robert Califf, MD, is the only person to have served twice as Commissioner of the U.S. Food and Drug Administration, confirmed in 2016 and again in 2022. A cardiologist by training, he founded the Duke Clinical Research Institute in 1996 and now teaches at Duke University School of Medicine.
What is Robert Califf an expert in?
Robert Califf’s expertise spans drug and device regulation, clinical trial design and evidence standards, FDA policy and administrative process, and cardiovascular medicine. He is one of the most cited medical researchers in the world, with more than 1,300 peer-reviewed publications.
How does Robert Califf describe the role of the FDA Commissioner?
Robert Califf distinguishes the commissioner from the career staff. He describes civil servants as the referees who apply the rules impartially to individual products, and the commissioner as the coach who sets policy and argues bad calls. In his framing, the rules themselves are written by Congress, not the agency.
What is Robert Califf’s view on US competition with China in biotechnology?
Robert Califf argues that the United States cannot contain Chinese biotechnology and should not try. He notes that a phase one trial can run in China at roughly a third of the US cost and six months faster, and that the American bottleneck sits with slow, expensive research sites rather than with the FDA. He favors an American strategy built on coexistence.
On Open Door Salon
“Former FDA Commissioner Robert Califf on RFK Jr., the FDA Exodus, and China”
Robert Califf & Vid Desai · July 22, 2026
Episode page & show notes on Open Door Salon
In this episode
- What leadership turnover does to an agency
- The rulebook, the referees, and the coach
- National priority vouchers and the administrative record
- Podium policy and what makes change stick
- Elsa, AI funding, and the money that runs out
- China, Operation TrialBlazer, and the missing US strategy
Topics
Watch on Open Door Salon
Open Door Salon brings life-sciences leaders into candid conversation. Every Monday, the week's takeaways land in your inbox.
Subscribe on Substack →