- U.S. Senator Edward Markey (D-MA) has placed a 'hold' on the nomination of Robert Califf for FDA Commissioner, temporarily blocking the Senate from voting on his nomination, reports the Boston Globe.
- By using this parliamentary procedure, Markey hopes to pressure the FDA to change its approach to approvals of opioids. Specifically, he wants the FDA to reverse its August 2015 decision approving OxyContin for pediatric use as well as to begin convening advisory panels for future opioid approval processes.
- Markey's public pushback against the FDA's stance on opioid approvals dates back to September 2015, when Markey and seven other senators penned a letter to the FDA protesting its decision on OxyContin pediatric use.
Ever since the FDA broadened the label for Purdue Pharma's OxyContin (ER oxycodone) to include 11 to 16-year-olds in August, critics have been highlighting the dangers of addiction. That version of OxyContin is a reformulated version, although doctors have been prescribing OxyContin off-label to children for some time.
Painkillers are the second most abused group of psychotherapeutics (after marijuana) among children aged 12 to 17, according to the Substance Abuse and Mental Health Services Administration.
Senator Markey (D-MA) is part of a vocal group of lawmakers who have strenuously protested this approval—and is using his hold to draw attention to the issue. Senator Murkowski (R-AK) has separately blocked Califf's nomination, although she is angered by the FDA's approval of genetically modified salmon.
Presidential candidate and Senator Bernie Sanders (I-VT) on Tuesday joined Markey, announcing he has placed a hold on Califf's nomination, citing his concern that Califf's close ties to the pharmaceutical industry will shape his judgment. He also agreed with Markey that the FDA should change its approach to opioids.
"Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,” Sanders said in a statement.
According to Senate rules, one Senator is allowed to block a nomination vote unless 60 Senators vote to overrule the hold.
While it's not likely Califf's nomination will be held up indefinitely, the efforts of the three Senators to block Califf from moving forward highlight lawmakers' concerns over the approvals process at the FDA.