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Robert Califf

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.

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

“It looks somewhat like a kleptocracy, that is the political oversight is heavily influenced by who’s giving money and who’s benefiting, as opposed to the scientific merit.”Robert Califf, on Open Door Salon (on political influence over scientific review)
“Trying to wall ourselves off from China is a doomed strategy. It won’t work.”Robert Califf, on Open Door Salon (on US-China biotech strategy)
“I don’t see the commissioner as a referee. I see the civil servants as referees. I see the commissioner is more like the coach.”Robert Califf, on Open Door Salon (on the commissioner’s role)

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

FDADrug RegulationClinical TrialsRegulatory PolicyCardiologyClinical ResearchUS-China BiotechEvidence Generation

Watch on Open Door Salon

Former FDA Commissioner Robert Califf on RFK Jr., the FDA Exodus, and China | Califf & Desai

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