On Tuesday, February 15, Robert Califf, PhD, was confirmed by the US Senate to the position of commissioner of the Food And Drug Administration by a vote of 50-46. It is Dr. Califf’s second stint in the position—the first, a brief one, came at the end of the Presidential Administration of Barack Obama, in 2015 and 2016.
Dr. Califf’s nomination and appointment was unusually contentious, as key stakeholders from both major US political parties withheld votes to confirm the prominent cardiologist and clinical trial specialist. For more on the politics of Dr. Califf’s nomination, including why key Senators such as West Virginia’s Joseph Manchin and Vermont’s Bernie Sanders withheld votes to confirm Dr. Califf’s nomination, read the December 2021 issue of the PRIM&R Member Newsletter (must be a PRIM&R member and log into the Knowledge Center to access).
With a decades-long background in thought leadership on clinical trials, including founding the Duke Clinical Research Institute, Dr. Califf will enter office with substantial experience in both public and private research. One of Dr. Califf’s priorities throughout his career has been the improvement of data collection and sharing within research, including the use of real-world evidence, health record optimization, and research data transparency, according to RAPS and STAT.
In 2017, Dr. Califf gave a keynote address at PRIM&R’s Advancing Ethical Research Conference in San Antonio, Texas called “The Continuum from Truth and Knowledge Generation to Opinion to False Information: Do We Have the Right Balance?” In it, he discussed real-world evidence, learning health care systems, and how the amount of health information technology has allowed access to has created ethical and logistical challenges that we must now grapple with.
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