US President Joe Biden has nominated Robert Califf, a former US Food and Drug Administration commissioner, to lead the FDA again. The agency has been without a permanent leader since January.
Califf is a cardiologist and a professor of medicine at Duke University. He was vice chancellor for clinical and translational research at Duke until he first joined the FDA in 2015. He served as the FDA commissioner from February 2016 until January 2017 under former president Barack Obama. He has since been head of clinical policy and strategy at Verily Life Sciences, a company owned by Alphabet Inc., Google’s parent company.
Drug developers welcomed his potential return to the FDA.
“Dr. Califf is an excellent choice to lead the FDA at this critical juncture,” says Michelle McMurry-Heath, president and CEO of the biotechnology advocacy group BIO. “He’s a proven leader whose on-the-job experience and deep understanding of the agency will allow him to hit the ground running,” she says in an emailed statement.
But some critics and lawmakers have raised concerns about Califf’s ties to industry, including his work as a consultant for large pharmaceutical companies.
“Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries,” Michael Carome, the director of the health research group at the consumer advocacy group Public Citizen, says in a statement.
If the US Senate confirms him, Califf will be tasked with rebuilding trust in a beleaguered FDA. The regulatory review of COVID-19 vaccines and antivirals has put the agency in the spotlight, and perceived political meddling has undermined confidence in the agency’s independence and science-driven approach.
The FDA’s approval of Biogen’s Alzheimer’s drug aducanumab in June has also taken a toll. Critics have questioned the quality of the evidence supporting this decision, as well as the steps that led to the approval. There are multiple ongoing investigations into aducanumab’s approval.
In 2016, Califf upheld the contentious accelerated approval of Sarepta Therapeutics’s Duchenne muscular dystrophy drug eteplirsen, despite similar concerns from some FDA staffers and external critics.
Califf will also have to address hiring hurdles at the FDA. “Stakeholders overwhelmingly consider the hiring process to be inefficient and ineffective,” according to a 2020 report. Ongoing negotiations between the FDA and industry also flag a need for more capacity to oversee the growing cell and gene therapy pipeline.
Other items on Califf’s to-do list could include increasing the use of real-world evidence in drug review, addressing the lack of patient diversity in clinical trials, and regulating e-cigarettes.
Califf’s nomination is pending in the Senate. In 2016, the Senate voted 89-4 to confirm Califf.