Senator Markey places hold on Obama's nominee to lead FDA

Reuters News
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Posted: Jan 25, 2016 1:23 PM

(Reuters) - Democratic U.S. Senator Edward Markey of Massachusetts said on Monday he has placed a hold on President Barack Obama's nominee to head the Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers.

Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee should consider the risk of addiction and abuse during the approval process. He also wants the agency to rescind approval of OxyContin for children and convene an advisory panel to guide that process.

"Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment," Markey said in a statement.

The nominee, Dr. Robert Califf, a cardiologist and researcher, is widely expected to ultimately be approved when the Senate votes on the nomination later this year, though critics argue his ties to the pharmaceutical industry are too close.

The Senate Committee on Health, Education, Labor and Pensions voted earlier this month to confirm Califf as FDA Commissioner, a position that has been open since Dr. Margaret Hamburg stepped down last February.

Republican Senator Lisa Murkowski of Alaska voted in favor of moving the nomination to the full Senate, but repeated a threat to oppose it if the FDA does not satisfy her demand for mandatory labeling of genetically engineered salmon.

Califf joined the FDA a year ago as a deputy commissioner. He is a prominent cardiologist who previously held senior positions at Duke University where he founded a large academic research center that received more than half of its funding from the drug industry.

He has also led multiple large-scale company-funded clinical trials and published more than 1,200 papers. His interest in streamlining the clinical trial process dovetails with those of patient groups and members of Congress who are eager to see new drugs brought to the market faster.

(Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama and David Gregorio)