After nearly ten months without a permanent commissioner, US President Joe Biden has nominated Robert Califf, former head of the Food and Drug Administration (FDA), to lead the agency once again. Although some in the research community are opposed to the nomination because of Califf’s ties to industry, others welcome a permanent director after such a long delay, particularly amidst the COVID-19 pandemic, in which the agency plays a crucial part.
A cardiologist, Califf had a long career at Duke University School of Medicine, where he founded the Duke Clinical Research Institute, the world’s largest academic clinical research centre. Since leaving the FDA in 2017, after serving as commissioner for less than 11 months, he has led clinical policy and strategy at Verily, the life sciences spin-off from Google’s parent company, Alphabet.
Despite his qualifications, some experts worry that Califf is too cosy with the industries that the FDA is charged with regulating. Califf is a board member of Cytokinetics, a biopharmaceutical company, and has received consulting fees from pharmaceutical and biotechnology firms Merck, Amgen, Biogen, Genentech, Eli Lilly and Boehringer Ingelheim.
Michael Carome, the director of the health-research group at Public Citizen, a consumer activist group in Washington DC, says he opposed Califf’s nomination in 2015 and opposes it now. “This is a crucial moment for restoring confidence in the agency and demonstrating that new leadership is needed to restore that public confidence by having someone that would act in the public interest — and only in the public interest,” he says.
When Califf was nominated in 2016, the Senate did not hold a final vote on his confirmation for more than five months because of stiff opposition from several Democrats. In particular, West Virginia senator Joe Manchin criticized Califf’s ties to the pharmaceutical industry and suggested that the cardiologist would not adequately address the ongoing opioid epidemic. Nevertheless, the Senate confirmed Califf in an 89–4 vote. Manchin has once again signalled that he has significant reservations about Califf’s renomination, but experts say they expect the confirmation to go through.
During his previous tenure as commissioner, Califf was criticized for the controversial accelerated approval in 2016 of a drug called eteplirsen for Duchenne muscular dystrophy, a rare terminal disease that leads to difficulties with movement. Woodcock, who was then head of the agency’s drug-review division, approved the drug by overruling the FDA’s independent advisory group, which argued that there was insufficient evidence that the treatment was effective. As director, Califf did not override Woodcock’s decision.
A similar situation played out at the agency in June this year, when the FDA approved Biogen’s controversial Alzheimer’s drug aducanumab over the objections of an advisory panel. Carome says he thinks the decision was precipitated by the weak precedent set by the eteplirsen approval.
After several members of the panel resigned in protest, Woodcock called for a federal investigation of the approval and acknowledged that some of the communications between staff members and Biogen “may have occurred outside of the formal correspondence process.” How Califf might respond to the investigation, set to conclude in 2023, remains to be seen.
Califf looks to be the chosen personal rubber stamper for pharmaceutical interests while posing as some type of guardian for the good.