ASHINGTON — Dr. Robert Califf won approval from a key Senate committee on Tuesday to become the next Food and Drug Administration commissioner, but one senator says she’ll block his path to a full Senate vote because of a dispute over genetically modified fish.
The Senate Health, Education, Labor, and Pensions Committee approved Califf’s nomination by voice vote, with no senators voting against him. Normally, that would be a sign that the Duke University cardiologist can expect an easy confirmation by the full Senate.
But Senator Lisa Murkowski, a Republican from Alaska, said she will place a “hold” on his nomination to prevent a Senate vote, saying she’s angry about her treatment by Califf and the FDA when she raised concerns about the agency’s plans for the labeling of genetically modified fish.
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Murkowski, who wants mandatory labeling, says she talked to Califf about the issue after the committee’s confirmation hearing in November, and that he promised to listen to her concerns. But shortly after the hearing, the FDA issued guidelines that called for voluntary labeling of genetically modified foods, not mandatory labeling.
Murkowski is convinced that voluntary labeling won’t work because not enough companies will comply — and she told reporters that Califf was “not straightforward” with her about what he knew about the FDA’s plans. She also said a Department of Health and Human Services official who was supposed to discuss the issue with her merely called her office after hours and left a message.
Califf, who came to the FDA early last year, got a warm reception from the Republican committee members at his confirmation hearing in November — warmer than GOP lawmakers usually give to one of President Barack Obama’s nominees.
But since then, he has had to spend time addressing concerns from Democratic committee members — especially Senator Bernie Sanders of Vermont, the presidential candidate, and Senator Elizabeth Warren of Massachusetts. They’ve grilled Califf on his close ties to pharmaceutical companies and the impact of their funding on research he oversaw at Duke.
Ultimately, their complaints didn’t cause any problems for the committee vote Tuesday. Warren didn’t object to his nomination, and Sanders, who has been out on the campaign trail, didn’t show up. In a statement, Warren said she has looked into Califf’s record and is “satisfied that he has conducted himself with integrity as an academic researcher.”
In written responses to follow-up questions from Warren, Califf said he and his Duke Center did not permit its pharmaceutical industry funders to influence the outcome of the studies — although he acknowledged their input into the design.
He also agreed with Warren about some of the problems he believes FDA needs to address, including the lack of data on the effects of medication in pregnant and lactating women; the need to develop alternative treatments for pain management using non-opioid pain medications; and antibiotic resistance.
Califf has a reputation for being industry-friendly and Republicans mostly want to make sure Califf will move to ease regulations. But there, too, Califf has been careful not to give Democrats any more ammunition against him.
In another set of written questions after the November hearing, committee chairman Lamar Alexander of Tennessee asked Califf how he would address “barriers to innovation,” referring to a 2014 presentation in which Califf said regulation can be a “barrier to disruptive innovation.”
Rather than use the opportunity to criticize federal rules, Califf suggested that Alexander misinterpreted what Califf was trying to say in the presentation.
“I have never stated, implied, or argued that the barrier should be lowered or removed,” Califf wrote. “In fact, I do not believe that we should be putting inferior medical products on the market, nor do the American people want inferior products to be used in medical practice.”
“The belief that we should have evidence of benefits and risks before marketing in health care has been a driving force in my career,” he wrote.
Califf’s other responses to Alexander’s questions give a good indication of his priorities for FDA.
If confirmed, Califf wrote, he will continue FDA’s efforts to revise its policies on allowing drug and medical device companies to promote “off-label” uses of their products. The agency has strict rules in place about when the industry can promote uses other than the approved ones, but in the past year, a federal appeals court said that manufacturers’ First Amendment rights permit them to convey truthful information about their products, whether they’re used “off-label” or not.
Califf wrote that he wants to review the FDA’s restrictions to “harmonize the goal of protecting the public health with First Amendment interests.”
Califf also advocates reforming the clinical trials system in order to reduce cost and speed results.