On February 15, the U.S. Senate confirmed Dr. Robert M. Califf as Commissioner of the Food and Drug Administration. As our readers know, Dr. Califf is internationally recognized as an expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine, and also served as the FDA Commissioner under former President Barack Obama from February 2016 until January 2017.

During a December 14 hearing, Dr. Califf stated that his top priority would be the ongoing COVID-19 pandemic and the agency’s preparation for future outbreaks: “The FDA must continue to be a strong partner in battling COVID-19, taking into account lessons learned from the pandemic so we can apply them to the ongoing current pandemic, and so we are ready for the next one.”

Dr. Califf will replace Dr. Janet Woodcock, who has been serving as the Acting FDA Commissioner since January 20, 2021. In a statement posted to Twitter following Dr. Califf’s confirmation, Dr. Woodock stated she will become Principal Deputy Commissioner, essentially FDA’s second-in-command.

President Biden nominated Dr. Califf in November 2021, and was expected to have a swift confirmation process based on the bipartisan support he received in 2016. However, Dr. Califf’s nomination faced significant opposition, as evidenced by the narrow confirmation vote of 50-to-46, largely due to Dr. Califf’s prior work with the pharmaceutical industry.