The Food and Drug Administration, which regulates about a quarter of every dollar Americans spend, has a new boss — and he's already under fire for being too cozy with the pharmaceutical industry.
Dr. Robert M. Califf, a cardiologist and researcher, was nominated by President Barack Obama in September to become the new commissioner of the agency. His confirmation by the Senate was delayed by lawmakers, many of them Democrats. They flagged concerns that his links with the pharmaceutical industry would bias his ability to regulate that business and that the FDA hasn't been aggressive enough in addressing the opioid-abuse crisis in America.
"F.D.A. stands for Food and Drug Administration, but over the last 20 years it really stands for 'fostering drug addiction,'" Sen. Edward J. Markey (D-MA), said in a Senate floor speech on Wednesday.
Despite the reservations, Califf was officially confirmed to the position in an 89 to 4 vote.
Califf has worked with many drugs companies, as both a paid consultant and through his research. As Scientific American points out, "In a recent article in the New England Journal of Medicine, Califf listed over a dozen pharmaceutical companies in his conflict-of-interest disclosure."
Unlike previous commissioners, he did not come from a public health background. Instead, the New York Times reported, he "ran a multimillion-dollar clinical research center at Duke University that received more than 60 percent of its funding from industry."
In fact, the Duke Clinical Research Institute is the only major institute housed at a university with which the FDA works, and it's presided over studies that have been hugely controversial — and favorable to the drug industry.
The institute was charged with reanalyzing the data behind Avandia, once one of the most prescribed diabetes medicines in America. When data started to emerge that Avandia increased patients' risk of heart attack and stroke, the drug was pulled from the market in several countries, and the FDA restricted access here.
But the Avandia drugmaker, GlaxoSmithKline, appointed the Duke group to go over the raw data behind Avandia again. The Duke researchers came out in favor of the drug, although other independent researchers thought that the pill should be abandoned because of safety concerns. Influenced by Duke's findings, the FDA decided to keep the drug on the market in 2013.
A blessing and a curse
Daniel Carpenter, a Harvard professor who has researched the FDA, views Califf's appointment as a blessing and a curse.
"In some sense, he's the ultimate industry insider, meaning he didn't spend his entire career in industry, but given his role at Duke and the arrangements there, he knows the industry very well," Carpenter explained. "The blessing aspect there is that it's a very complicated field, and it's important to have someone in the commissioner's position who is credible and legitimate."
Proponents of Califf have pointed out that he has managed to retain his independence despite the industry ties, and that his work with pharma is simply a sign of the times. They've also noted that the FDA will benefit from Califf's knowledge as one of the world's leading experts in clinical trials design. All told, more than 130 health groups, including the prestigious New England Journal of Medicine, have backed him.
But, Carpenter added, Califf is taking over at a time when there's been a movement in Washington, largely supported by the pharmaceutical industry and industry-backed patient groups, to relax and erode the evidentiary standards for the approval of new medicines and medical devices.
"Given where Califf is from and the role that Duke has played in generating a lot of ideas about the relaxation of standards," Carpenter said, "one worries about whether he has been listening to a certain subset of voices over the past 10 or 20 years that tilt in that direction."
A key challenge: speeding up innovating and drug approvals without sacrificing quality
Perhaps the biggest challenge Califf will face is balancing the pressure to speed up FDA drug approvals while still ensuring only safe and effective drugs are getting to market.
Califf's tenure comes at a time when the FDA is already approving a stunning 96 percent of drug applications it receives from industry. Some medical researchers are concerned that the FDA is waving through ineffective and potentially harmful drugs too quickly — sleep drugs with marginal benefits that can cause car accidents, a libido enhancer for women that barely works better than a placebo. (Here's our Vox story on that.)
Several pieces of proposed legislation could further speed up drug approvals by lowering the standards of evidence that the agency uses to make decisions about drugs.
As Yale researcher Gregg Gonsalves told Vox, "Califf takes over the agency in a time of peril. Whether he will rise to the occasion and protect the public health and public interest or surrender to private ones is to be seen."