Dr. Robert Califf, the former Food and Drug Administration commissioner who heads clinical policy and strategy for South San Francisco-based Verily Life Sciences and Google Health, reportedly is President Joe Biden's top pick to lead the FDA — again.
Califf's nomination is not final and the job requires confirmation by Congress, Politico and other sites reported. But whoever does take the job would lead an agency perpetually in the crosshairs for its drug approval decisions or for how it carries out regulation as scientific discoveries in drugs, devices and diagnostics continue to advance.
The FDA job is that much more fraught with decisions pending on the expansion of coronavirus vaccines for children and booster shots in adults, as well as this summer's controversial approval of an Alzheimer's Disease drug with debatable efficacy.
"I appreciate that regulation is based on a whole history of events and laws and federal rules and guidances and court cases that create a kudzu, a fabric, of decision making grounded on precedent. And that's hard to unravel, and I say that's a good thing," Califf said in a 2017 interview with the Business Times.
The FDA commissioner job is now one of two major federal health care positions Biden must fill. The other post is director of the National Institutes of Health, a position being vacated by retiring longtime leader Francis Collins.
Califf, a well-respected cardiologist and former vice chancellor for health data science at the Duke University School of Medicine, would go into the FDA job with eyes wide open: He headed the agency under President Barack Obama in 2016-17 and was deputy commissioner for medical products and tobacco at the FDA in 2015-16.
Bernie Sanders could object to Califf's industry ties
Califf's ties to the biopharmaceutical industry, Politico reported, could be cause for concern by Sen. Bernie Sanders. Also, Sen. Joe Manchin and others had concerns during Califf's confirmation hearings.
But Califf's scientific acumen and smooth demeanor could be a plus at an agency in flux and with tough decisions to make.
The FDA is dealing with the fallout from its decision in June to approve Biogen Inc.'s Aduhelm, or aducanumab, despite little evidence of benefit for Alzheimer's patients. At the same time, drug makers and patient advocates have criticized the agency for moving too slowly in approving or setting up a framework for approval of drugs with few or no treatment options.
Califf, who trained at the University of California, San Francisco, and was an adjunct professor at Stanford University, was brought into Verily as an advisor in 2017.
Initially funded by Alphabet Inc. (NASDAQ: GOOG), Verily has dipped into and out of a number of projects. Its most ambitious program is its Project Baseline, which is aimed at collecting and analyzing data from about 10,000 people to better understand health and sickness.
"The question is, how do we take that data and turn it into actionable information so it's appealing to people so their behavior changes to lead to healthier lives? That is a huge problem," Califf said at the time.