While the new head of the FDA’s nomination process was moving smoothly, on Monday it hit a new snag. Democratic U.S. Senator Edward Markey of Massachusetts announced he placed a hold on on the nomination until the FDA 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 their August 2015 approval of OxyContin for children and convene an advisory panel to guide that process.
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, was widely expected to be approved when the Senate votes on the nomination later this year, although critics, including Presidential contender Bernie Sanders, argue his ties to the pharmaceutical industry are too close.
Call for Review of FDA Approval of Oxycontin for Kids
Last August 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. This approval resulted in Senators calling for an investigation into the FDA’s decision. They also asked in the letter to the Senate Health, Education, Labor and Pensions Committee on Wednesday for an investigation into the rise in opioid abuse and overdose deaths.
In response to the hold placed by Senator Markey a spokesman for the Department of Health and Human Services, which oversees the FDA, said it had made addressing the opioid crisis “a top priority” and that they would be in touch directly with the Senator regarding his concern.
The nomination seemed to moving along nicely once the Senate Committee on Health, Education, Labor and Pensions finally voted earlier this month to confirm Califf as FDA commissioner, a position open since Dr. Margaret Hamburg stepped down nearly a year ago. Califf, who joined the FDA 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. As MedCareerNews noted, 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 and may signal changes at the FDA if his nomination is approved.
Rising death rate for White Americans
Concern from the Senator is based on the recent shock when the rising death rate for middle aged white Americans was announced. As MedCareer News reported, drug overdoses are seen as a major contributor to this national problem. According to the U.S. Centers for Disease Control and Prevention U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5 percent to 47,055, propelled by prescription painkiller and heroin abuse. Since 2000, deaths from powerful, highly addictive opioids have jumped 200 percent, the CDC said, with those addicted to prescription painkillers, such as hydrocodone, increasingly turning to widely available, often cheaper heroin.
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Lindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.