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Three senators now holding up FDA nominee — for three different reasons

Two additional senators have announced plans to stall the confirmation of a new Food and Drug Administration commissioner, with one citing the nominee's relationship to the pharmaceutical industry and the other saying the agency needs to reform the way it approves powerful opioid painkillers at the heart of a national epidemic of overdoses.

Vermont senator and Democratic presidential candidate Bernie Sanders said Tuesday that he would place a hold on the confirmation of former Duke University researcher and cardiologist Robert Califf, President Obama's nominee to head the FDA. His reason: Califf's "close ties to the pharmaceutical industry and lack of commitment to lowering prices."

Sanders becomes the third senator standing in Califf's way. On Monday, Sen. Edward J. Markey (D-Mass.) said he had placed a hold on the confirmation until the agency agrees to several measures related to the use of opioid painkillers such as oxycodone and hydrocodone. Markey wants the FDA to rescind its recent approval of OxyContin for children as young as 11, to make abuse and dependence issues a factor in which opioids are considered "safe" and to automatically convene advisory committees for recommendations on future opioid-related decisions.

"Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs," Markey said in a statement Monday. "The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf's nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family."

The Centers for Disease Control and Prevention said recently that nearly 30,000 Americans died from heroin and prescription opioid overdoses in 2014, the highest annual number on record. More than six in 10 drug overdose deaths were caused by opioids that year as the prescription drug epidemic worsened and the pace of heroin fatalities surged, the CDC said.

[Why the FDA approved OxyContin for kids as young as 11]

Officials at the FDA, where Califf currently serves as a deputy commissioner, had no immediate comment to either lawmakers' announcements. But during a confirmation hearing late last year, Califf did address the issue of industry funding of his research at Duke.

"I think if you look at my record, I've never been a proponent of lowering standards. If anything I've argued for raising them," he told lawmakers. "I think I've been staunch in that regard."

Sanders remains unswayed, saying in in a new statement that "we need a leader at the FDA who is prepared to stand up to the drug companies. Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans." 

[FDA nominee faces questions about drug industry ties]

Earlier this month, a Senate health committee voted unanimously to advance the nomination to the full Senate. Just before that vote, Sen. Lisa Murkowski (R-Alaska) told her colleagues that she intended to hold up Califf's nomination until the FDA agrees to mandatory labeling requirements for genetically engineered salmon.

The AquaAdvantage salmon, produced by Massachusetts-based AquaBounty and approved by the agency in November, is an Atlantic salmon that contains a growth hormone from a Chinook salmon and has been given a gene from the ocean pout, an eel-like fish. The result is a fish engineered to grow twice as fast as its natural counterpart. It is the first genetically altered animal approved for human consumption and was the subject of long-running fights involving food-safety activists, environmental groups and the salmon fishing industry.

Murkowski helped insert language late last year in a massive federal spending bill, directing the FDA to prevent the product from reaching the market until regulators finalize labeling guidelines. She said this month that "voluntarily labeling is not adequate. I’m going to be pushing for further conversations with Dr. Califf on this."

Generally, though, Califf enjoys broad support on Capitol Hill. Should the senators who have held up a vote on his confirmation lift their opposition, he is expected to be confirmed for the FDA post.


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