President Joe Biden on Nov. 12 announced he will nominate cardiologist Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA), a key role as the government continues to combat the ongoing coronavirus pandemic. Current Acting FDA Commissioner Janet Woodcock’s term ends Nov. 15.
Califf, 70, who previously led the FDA during the Obama administration from February 2016 to January 2017, is currently the senior advisor for health technology firm Verily Life Sciences and its sister company Google Health.
Biden called Califf one of the most experienced clinical trialists in the country. “As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” Biden said in a statement. “I am confident Dr. Califf will ensure that the FDA continues its science and data drive decision-making.”
U.S. House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) commended the president’s choice, saying Califf played a key role in helping Congress shape and pass the 21st Century Cures Act during his first tenure as FDA commissioner, and “is a proven leader who will bring a wealth of knowledge and expertise upon his return to the agency.”
The president’s pick for FDA commissioner follows criticism from both Republicans and Democrats who have complained that a Senate-confirmed, permanent leader at FDA was necessary months earlier in Biden’s presidency to ensure public confidence in COVID-19 vaccine approvals.
U.S. Sen. Joe Manchin (D-WV) on Friday said he opposes Califf’s nomination due to the doctor’s ties to the pharmaceutical industry. Manchin also said he didn’t support Califf’s nomination in 2016, although Califf ultimately was confirmed by the Senate with broad bipartisan support.
“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic. Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Manchin said in a statement.
Prior to Califf’s previous stint as FDA commissioner, the doctor reported receiving personal fees for consulting from at least 19 major pharmaceutical manufacturers, including Amgen, GlaxoSmithKline, Johnson & Johnson, Novartis, and Pfizer, according to Michael Carome, director of Public Citizen’s Health Research Group.
“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,” Carome said. “And in February 2018, he was appointed to the board of directors of the biopharmaceutical company Cytokinetics.”
U.S. Sen. Maggie Hassan (D-NH), a member of the Senate Health, Education, Labor, and Pensions Committee, said, “As we continue to combat both the COVID-19 pandemic and the substance misuse epidemic that continues to plague New Hampshire families, we must have an FDA Commissioner that acts independently from the pharmaceutical industry, makes decisions based on the science, and puts the health and safety of Americans first.” Hassan added in a statement that she was troubled by some of the FDA’s previous decisions, including those related to the approving and labeling of opioid-based medications.
Califf is also well-known as the founding director of the Duke Clinical Research Institute and served as vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, which is Duke’s center for health data science; and as the Donald F. Fortin, MD, Professor of Cardiology. Prior to serving as FDA commissioner, Califf also served as deputy commissioner for medical products and tobacco at the FDA from 2015 to 2016.