Emily Kopp, Roll Call: November 12, 2021
President Joe Biden is expected to tap Robert Califf to again serve as commissioner of the Food and Drug Administration.
Califf, who previously helmed the FDA in the final year of the Obama administration, is seen as a status quo choice.
Independent experts say Califf has decades of experience in the development and conduct of clinical trials. That resume has brought Califf in frequent contact with both the FDA and the pharmaceutical industry he would be charged with regulating.
Califf had such strong bipartisan support that when Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader.
“My feeling about Califf is that he’s a political compromise. His nomination shows the power of pharma. But despite his close ties to pharma, he has always talked about the importance of solid scientific evidence.” said Diana Zuckerman, president of the National Center for Health Research, a think tank in Washington, D.C. “I have some confidence that Dr. Califf is not someone who likes controversy. That is different than Dr. Woodcock who doesn’t seem to mind controversy at all. I’m hopeful he will really focus on the science in a way that has been missing lately at FDA.”
Califf is a longtime cardiologist and a professor in the school of medicine at Duke University. Califf also served as founding director of the Duke Clinical Research Institute, a partnership between the university and pharmaceutical companies with the goal of innovating clinical trial design. He led it for a decade. The research institute receives about half of its funding from the pharmaceutical industry and half from the government, according to a 2020 report. He founded the Clinical Trials Transformation Initiative, a collaboration between the FDA and Duke on improving the speed and reducing the cost of clinical trials, which collaborates with pharmaceutical companies.
Califf is also an executive at Verily Life Sciences, formerly Google Life Sciences, an Alphabet Inc. company.
But Califf has in several public statements voiced support for more patient input at the FDA.
Critics say this advocacy is often financed by the pharmaceutical industry, and the FDA often does not distinguish between authentic advocacy and these conflicts of interest.
Califf has also called for other changes to clinical trials supported by the pharmaceutical company, including greater reliance on real-world evidence pulled from electronic health records outside of a clinical trial and on biomarkers, biological signals a drug is working before it shows a clinical benefit.
“Of course, the devil’s always in the details. It’s fine to be supportive, for example, of biomarkers as a way to get information about potential benefits but it needs to be backed up by solid science,” said Zuckerman.
At the FDA, Califf would likely have to respond to an ongoing investigation by the Health and Human Services inspector general into the approval of the Alzheimer’s drug aducanumab. It was approved through FDA’s accelerated approval pathway based on the difference it made with a controversial biomarker, amyloid plaques.
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