Senate Confirms Robert M. Califf as FDA Commissioner

The US Senate has confirmed Robert M. Califf, MD, a prominent cardiologist and expert in clinical trials, as the latest FDA commissioner today in a 50-46 vote.¹ The agency had been without a permanent leader for more than 1 year.

Califf, an adjunct professor of medicine (cardiology) at Duke University School of Medicine and the founding director of the Duke Clinical Research Institute (DCRI), served as the FDA’s deputy commissioner for Medical Products and Tobacco from February 2015 to February 2016, when he was appointed FDA commissioner. He held that position until 2017. More recently, Califf served as a senior adviser for Google Health, and head of clinical policy for Verily Life Sciences, a biotechnology startup spun off from Google’s parent company, Alphabet.

Several prominent physician groups, including ASCO, the American Heart Association (AHA), and American Association for Cancer Research, previously expressed their support for Califf’s candidacy. ASCO board chair Howard A. “Skip” Burris III, MD, issued a statement in which he stated that Califf was “extraordinarily well-suited to lead the FDA” and praised his commitment to clinical and translational medicine that stretches back to the 1970s.²

“As a former FDA Commissioner, Dr Califf has demonstrated a deep commitment to protecting public health and has experience leading large and complex organizations, which is critical as we continue to respond to an unprecedented global pandemic,” Burris said. “We look forward to continuing our productive history of collaborating with Dr Califf and the FDA in reducing cancer incidence, advancing treatment options, and improving the lives of people with cancer.”

Califf’s nomination faced opposition from Republicans because the FDA eased restrictions on the so-called “abortion pill” when he was with the agency in 2016. Meanwhile, some Democrats were wary about his close ties with the pharmaceutical industry and complained that Califf did not do enough to regulate opioids during his previous tenure with the agency.

The White House made a late push to get reluctant senators onboard and the AHA released a letter backing his candidacy on February 10, 2022.³ In the end, Califf got just enough support.

“Throughout his career, Dr Califf has been a relentless force in the fight against heart disease and stroke,” Nancy Brown, chief executive officer of AHA, said in a statement congratulating Califf on his confirmation.⁴ “As FDA commissioner, Dr Califf will put this experience to work leading the agency’s critical efforts to protect and improve the public’s health.”

Califf earned his medical degree at Duke in 1978. He returned to Duke following the completion of his internship/residency at the University of California, San Francisco, and stayed there as a cardiologist, clinical investigator, and senior leader until joining the FDA in 2015.

He held a variety of roles at Duke, including the Donald F. Fortin, MD, Professor of Cardiology, and vice chancellor for Health Data Science. He also served as director of the Duke Translational Medicine Institute, and as founding director of the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Califf led major initiatives aimed at improving methods and infrastructure for clinical research at Duke, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership cofounded by the FDA and the university. He also served as the principal investigator for the school’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center.

“It’s hard for me to think of anyone who would be better prepared to lead the FDA, given the scope of Rob’s experience in patient care, research, and policy,” Amy Abernethy, MD, PhD, president of Verily’s clinical research business and a former professor of medicine at Duke, stated in a news release.⁵ Abernethy served as principal deputy commissioner and acting chief information officer at the FDA from February 2019 to April 2021. “The fact that he has led the FDA effectively before means that he will be able to get to work immediately on the most pressing issues on the agency’s to-do list. There is no question that Rob will be prepared to hit the ground running.”

References

1. Aboulenein A. U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time. News release. Reuters; February 15, 2022. Accessed February 16, 2022. https://reut.rs/3HYyexz
2. ASCO Congratulates Robert M. Califf, MD, on Confirmation as FDA Commissioner. News release. American Society of Clinical Oncology; February 15, 2022. Accessed February 16, 2022. https://bit.ly/3JAkidH
3. Leading cardiology groups urge swift confirmation of Robert M. Califf. News release. American Heart Association; February 10, 2022. Accessed February 16, 2022. https://bit.ly/3H31929
4. Robert M. Califf, MD confirmed to lead FDA. News release. American Heart Association; February 15, 2022. Accessed February 16, 2022. https://bit.ly/3HXYOH3
5. Robert M. Califf confirmed as commissioner for the US Food and Drug Administration. News release. Duke University; February 15, 2022. Accessed February 16, 2022. https://bit.ly/3I1d9m7