President Obama has nominated cardiologist Rob Califf to be the next head of the Food and Drug Administration, replacing the outgoing Margaret “Peggy” Hamburg.
The nomination is no surprise. Speculation that Califf could be the next commissioner gained momentum in late January when the FDA named him a top deputy. Two weeks later, Hamburg said she planned to step down.
Califf was a candidate for the top spot in 2009, but Obama gave Hamburg the nod. Califf has deep ties to Duke University, where he has held several positions. He was the founding director of the Duke Clinical Research Institute, a contract research organization within Duke that conducts clinical trials. He also ran the Duke Translational Medicine Institute and taught at the medical school.
Another one of Califf’s pursuits also ties in with the federal government’s new commitment to long-term studies that require sophisticated handling of genomic and other health data. He was lead investigator of a longitudinal health study in Kannapolis, NC, tracking heart disease, high blood pressure, cancer, and other diseases in residents of Kannapolis and surrounding Cabarrus County. Xconomy wrote about the study in July; its new director, Duke cardiologist Kristin Newby, said she hopes the study will become part of the federal Precision Medicine Initiative.
But as Califf heads toward nomination hearings, likely this fall, one immediate question for the biopharmaceutical world is whether he will carry forward Hamburg’s legacy. Under her watch, the agency tilted toward faster drug approvals and a smoother relationship with the industry.
Before Hamburg arrived, approvals of new and novel drugs languished—18 were approved in 2007, and 24 the following year—and the agency’s drug chief gave his reviewers leeway to miss their deadlines. Stung by criticism over the approval—and subsequent withdrawal—of the painkiller Vioxx, the agency increased the hurdles to approve drugs meant for wide patient populations.
But under Hamburg, the agency streamlined reviews, in part with faster timelines for drugs that promised to treat unmet medical needs. Those initiatives have helped boost approval numbers to near-record levels; 41 new and novel drugs were approved in 2014, the highest total since a record 53 in 1996.
In fact, it’s now rare for the agency to reject a drug, as Forbes’ Matthew Herper recently reported. The growing feeling that the agency is “providing a rubber stamp” to the drug industry, as Herper wrote, could become a point of contention in Califf’s Senate nomination hearings.
Those feelings have already surfaced in criticism of an FDA reform bill, known as 21st Century Cures, that passed the House of Representatives this summer. If it becomes law, it could speed up drug approvals even more. The Senate has yet to take up the bill.
In addition to building industry ties through Duke’s contract research organization, Califf has ties to at least two biopharma companies. He was on the medical advisory board of Regado Biosciences, and he held a board seat at Portola Pharmaceuticals. He resigned the seat when he joined the FDA earlier this year.
Xconomy Raleigh-Durham Editor Frank Vinluan contributed to this report.