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A second senator has announced plans to stall the confirmation of a new Food and Drug Administration commissioner, saying the agency needs to reform the way it approves a type of powerful painkillers at the heart of a national epidemic of overdoses from prescription drugs and heroin.
Sen. Edward J. Markey (D-Mass.) said Monday that he has placed a hold on the confirmation of former Duke University researcher and cardiologist Robert Califf, President Obama's nominee to head the FDA, 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 readl 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."
[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.
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.
Earlier this month, a Senate health committee voted unanimously to advance Califf's nomination to the the full Senate. But 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.
[FDA nominee faces questions about drug industry ties]
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."
Vermont senator and Democratic presidential candidate Bernie Sanders also has opposed Califf's confirmation, saying that his ties to research funded by major drug companies over the year call into question his ability to stand up to the pharmaceutical industry as head of the FDA.
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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