On Tuesday, the Obama administration nominated Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA). In a statement, director of the Public Citizen’s Health Research Group, Dr. Michael Carome called on the Senate to reject the nomination. He contends that Califf “racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few.”
“Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed,” wrote Carome.
Califf has served as the deputy commissioner for medical products and tobacco since March and is a researcher and the former director of the cardiac care unit at Duke University Medical Center.
Reuters reports that “Califf has close ties with the drug industry, having worked on myriad high-profile clinical studies, and he is also close with Dr. Janet Woodcock, the FDA’s powerful head of pharmaceuticals.”
In February, Diana Zuckerman, the president of the National Center for Health Research, told TIME that Califf’s ties to the industry “should be of great concern,” and that these relationships raise questions about his “objectivity and distance.” She cited studies suggesting that “such ties to influence the behavior and decision-making of doctors and researchers, even when the scientists don’t realize it.”
Califf graduated from the Duke School of Medicine in 1978, then completed his residency at the University of California, and a fellowship in cardiology at Duke. Califf has had a long research career, working in both development and post-marketing surveillance. He has also led large public–private partnerships with the FDA.
In Saturday’s New York Times, Sabrina Tavernise describes the close industry ties of Dr. Robert Califf, a cardiologist and researcher recently tapped by the Obama administration to head the FDA. In a conflict of interest statement published last year, Califf “declared financial support from more than 20 companies,” leading some public health advocates to “question whether his background could tilt him in the direction of an industry he would be in charge of supervising.” Tavernise points to a presentation Califf gave on “Disrupting Clinical Research: Transforming a System” in 2014 where he singled out regulation as a barrier to research and innovation. “I think it illuminates his thinking,” Daniel Carpenter, a Harvard professor who studies the FDA, said of the slide. “In a sense, he’s the ultimate industry insider.”