Califf, who joined the FDA a year ago after decades as a researcher and administrator at Duke University, was nominated by President Obama to run the agency last September. But in the months that followed, his nomination faced opposition from a handful of senators, over everything from the nation's prescription painkiller epidemic to genetically engineered salmon.
Democratic presidential candidate Sen. Bernie Sanders (Vt.) has staunchly opposed Califf’s confirmation, insisting that his professional history — a 2014 financial disclosure showed his salary at Duke was underwritten partly by funding from large drugmakers such as Eli Lilly and Merck, and drug companies helped fund research studies he oversaw — would prevent him from aggressively regulating the industry and looking out for ordinary patients.
Califf said in his confirmation hearing last fall that the drug companies routinely funds such studies and that working the industry is a modern necessity, but that Duke's contracts protected the independence of investigators to publish research outcomes, whatever the results. He said he had never advocated for lowering standards around the safety or efficacy of drugs and wouldn't as head of the FDA. He repeated that vow in an interview Wednesday.
"I think my record shows that I’m for medical products that work and are effective. When they’re not, I’ve been outspoken," Califf said shortly after his confirmation. "I think the best testament is that I went through an amazingly rigorous committee, hundreds of pages of written documentation, and then a full Senate review, and came out pretty well.
In addition to Sanders, Sen. Lisa Murkowski (R-Alaska) briefly stalled Califf’s nomination because she wanted the FDA to put in place labeling requirements for genetically engineered salmon, which the agency approved in a controversial decision last year. She later lifted her opposition.
The most ardent and sustained criticism of Califf's nomination came from Sens. Edward J. Markey (D-Mass.) and Joe Manchin III (D-W.Va.), who repeatedly expressed frustration over what they describe as the FDA’s lax approach to opioid painkillers amid an epidemic of prescription-drug abuse. The pair this week criticized the FDA’s recent promises to strengthen follow-up studies on painkiller use and to convene more outside expert panels before approving certain opioids as weak and unlikely to help combat the ongoing crisis. Both voted against his confirmation; they were joined only by senators Kelly Ayotte (R-N.H.), Richard Blumenthal (D-Conn.).
Markey and Manchin said they were disappointed with Califf's confirmation but would continue to push for more aggressive measures to fight opioid abuse.
“The fight I led against Dr. Califf was not personal. It was a fight to change the culture of the FDA starting from the top,” Manchin said in a statement. “I still believe that we must act now to change the culture at the FDA if we have any hope of stopping the prescription drug abuse epidemic that is ravaging our nation.”
Califf said Wednesday he agrees about the gravity of the painkiller epidemic in the United States. "The discussion is important, and it needs to be had," he said. "I don’t think anyone 10 years ago anticipated that these drugs would be associated with so much societal harm."
But he said the issue is multi-facted, involving not only how the FDA reviews opioid drugs but also how doctors prescribe them and whether patients in pain have adequate alternatives that are less addictive. Consequently, he said the solutions will take time and require widespread cooperation from people inside and outside the government. "This is going to take an effort by everyone involved," he said.
Califf, who has long been considered a likely candidate for the job, received broad support from some health and patient advocacy groups, including the American Heart Association, the Leukemia & Lymphoma Society and Friends of Cancer Research. Jeffrey M. Drazen, a Harvard Medical School professor and editor of the New England Journal of Medicine, wrote in an editorial last fall that lawmakers should confirm Califf “as soon as possible."
Califf succeeds Margaret A. Hamburg, who left the agency last March after a six-year tenure marked by a slew of new drug approvals, as well as efforts to overhaul the nation's food safety system and begin regulating cigarettes and other tobacco products for the first time. She also faced controversies, such as a problems related to a medical device used to remove uterine growths in women and tainted injections produced by largely unregulated compounding pharmacies. Stephen Ostroff, previously the FDA's chief scientist, has served as acting commissioner since her departure.
Califf inherits an agency facing an array of new responsibilities and potential changes. The FDA is continuing a years-long effort to implement a 2010 law aimed at revamping the nation's food safety system, in an effort to make it more proactive, rather than merely reacting to outbreaks after they happen. Federal regulators also are still figuring out how to regulate the vast tobacco industry, and the FDA is expected this year to release new regulations governing the booming market for e-cigarettes. At the same time, the FDA has been approving new drugs -- many of them innovative but expensive treatments for cancer and other diseases -- at a near-record pace in recent years.
But one piece of legislation working its way through Congress during the past year could alter the speed and manner in which the FDA approves drugs and medical devices. Advocates have said the bill would help accelerate the agency's reviews and get needed innovations to patients more quickly, though some experts worry the legislation could force the FDA to compromise its high standards for safety and efficacy in the name of speed.