Biden Taps Ex-FDA Head Califf as Next Commissioner
The Biden Administration has selected former FDA commissioner Robert Califf as its FDA commissioner nominee and he is projected by agency observers to easily win Senate confirmation. Faced with a looming legal deadline to nominate a candidate or risk losing acting commissioner Janet Woodcock’s temporary leadership, the White House went with the familiar Califf, who headed the agency during the last year of the Obama Administration. Woodcock can now continue in her acting commissioner capacity while Califf’s confirmation advances.
Califf, a cardiology professor at Duke University School of Medicine, had been confirmed on an 89-4 vote in 2/2016. Some senators had criticized his appointment because of his ties to drug companies that helped fund his research at Duke.
During his professional career, Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative, a public-private partnership co-founded by FDA and Duke. As commissioner, he helped advance then-vice president Biden’s National Cancer Moonshot Initiative. He directed creation of FDA’s Oncology Center of Excellence (OCE) and subsequently named CDER lead cancer official Richard Pazdur as OCE’s new head.
Responding to reports about the nomination, Public Citizen Health Research Group director Michael Carome said “Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries. The Senate therefore must reject Califf’s nomination and demand that Biden nominate an individual who has been dedicated to advancing public health — one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries.
“Califf has a long history of extensive financial ties to Big Pharma,” Carome continued, “most significantly through pharmaceutical industry funding to the Duke Clinical Research Institute, which he founded in 1996... During just the few years before his previous stint as FDA commissioner, Califf reported receiving personal fees for consulting from at least 19 major pharmaceutical manufacturers, including Amgen, GlaxoSmithKline, Johnson & Johnson, Novartis and Pfizer. After exiting the FDA, Califf revived his lucrative ties with FDA-regulated pharmaceutical companies, receiving consulting fees totaling tens of thousands of dollars from AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Eli Lilly, Merck Sharp & Dohme and Sanofi... Califf was a poor choice for FDA commissioner when he was nominated by Obama in 2015 and he remains a poor choice today.”
Meanwhile, Senator Joe Manchin (D-WV) said he opposes the Califf nomination because he contends that correcting the culture at FDA is necessary to help change the tide of the opioid epidemic in the U.S. “Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” he says. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction... I urge the administration to nominate an FDA commissioner that understands the gravity of the prescription drug epidemic and the role of the FDA in fighting back against the greed of the pharmaceutical industry.”