(Reuters) — Sen. Edward Markey (D-Mass.) yesterday put a hold on President Barack Obama’s nominee to head the FDA until the agency agrees to reform its process for approving opioid painkillers.
Markey wants 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.
A “hold” is a procedure by which a senator can prevent a measure from being voted on by the full Senate.
The nominee, Dr. Robert Califf, a cardiologist and researcher, is widely expected to be approved when the Senate votes on the nomination later this year, although critics argue his ties to the pharmaceutical industry are too close.
A spokesman for the U.S. Health & Human Services Dept., which oversees the FDA, said it had made addressing the opioid crisis “a top priority.”
“Work at FDA and across HHS will continue on this important effort,” spokesman Kevin Griffis said in a statement. “HHS will be in touch directly with the Senator regarding his concern.”
The Senate Health, Education, Labor & Pensions Committee voted earlier this month to confirm Califf as FDA commissioner, a position open since Dr. Margaret Hamburg stepped down last February.
Califf, who joined the FDA a year ago as a deputy commissioner, previously held senior positions at Duke University, where he founded a large academic research center that received more than half 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 market faster.
U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5% to 47,055, propelled by prescription painkiller and heroin abuse, according to the U.S. Centers for Disease Control & Prevention.
Drug overdoses are seen as a major contributor to recently rising death rates among middle-aged white Americans.
Since 2000, deaths from powerful, highly addictive opioids have jumped 200%, the CDC said, with those addicted to prescription painkillers, such as hydrocodone, increasingly turning to widely available, often cheaper heroin.