Robert Califf, US President Joe Biden‘s pick for the head of the Food and Drug Administration (FDA), will return to lead the regulatory agency following his controversy-marred tenure from February 2016 to January 2017. If confirmed by the Senate, Califf would oversee decisions on COVID-19 vaccines along with other contentious issues such as the regulation of electronic cigarettes. He would be the first FDA commissioner since the 1940s to return for a second stint leading the agency. The longtime cardiologist has also worked with Google’s parent company Alphabet.

Califf’s nomination as FDA commissioner by the Barack Obama administration faced opposition from several Democrats over alleged conflict of interest due to his ties to the pharmaceutical industry. He was ultimately confirmed by a vote of 89-4 in the Senate.

Joe Biden nominates Robert Califf as FDA chief

As head of the FDA, Califf oversaw the controversial 2016 approval of eteplirsen, a drug used to treat Duchenne muscular dystrophy (DMD), against the recommendations of its independent advisory group.

Dr. Ellis Unger, who was then director of the FDA’s Office of Drug Evaluation, publicly said he was concerned that the drug’s approval would leave the FDA “in the position of having to approve a myriad of ineffective treatments for groups of desperate patients.”

Califf had previously served as the FDA‘s deputy commissioner for medical products and tobacco. He was a professor of medicine and a vice chancellor for clinical and translational research at Duke University before joining the FDA. He was also the director of the Duke Translational Medicine Institute and is the founding director of the Duke Clinical Research Institute.

He served on the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Califf is a “nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research,” according to FDA.

He has also led many clinical trials and is “one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.”