Obstacles piling up for Obama’s FDA nominee

The snowed-out Senate session didn’t stop Sen. Edward Markey on Monday from blocking consideration of President Obama’s nominee to run the Food and Drug Administration.

Markey, D-Mass., announced he has placed a hold on Dr. Robert Califf, who Obama nominated in September to serve as FDA commissioner and who now faces opposition from several senators who are angry about recent FDA actions.

But Markey said the hold isn’t aimed at the nominee, and is instead a response to the agency’s approval process for opioid painkillers, which he said is “fueling a prescription drug and heroin overdoes crisis.”

Markey said he is calling on the FDA to restructure the way it approves future opioid use so that it weighs whether a drug is addictive or prone to abuse.

The FDA angered some lawmakers last year when it approved OxyContin as safe for children. Markey said the FDA should rescind the approval of OxyContin for kids.

“The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination,” Markey said in a statement. “Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”

Markey isn’t Califf’s only roadblock to the FDA helm.

Sen. Lisa Murkowski, R-Alaska, said she would put a hold on his nomination because of the FDA’s approval of genetically modified salmon for consumption. Sen. Bernie Sanders, I-Vt., who is running for the Democratic presidential nomination, said he may place a hold on the nomination in response to skyrocketing drug prices under the FDA’s watch.

Califf is a cardiologist and Duke University medical researcher now serving as as FDA Deputy Commissioner for Medical Products and Tobacco.

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