STEVE LeBLANC, Associated Press
BOSTON (AP) — U.S. Sen. Edward Markey is blocking Senate confirmation of a new commissioner for the Food and Drug Administration to call attention to the agency’s approval process for opioid painkillers.
The Massachusetts Democrat said Monday he’s placed a hold on nominee Dr. Robert Califf.
Markey says the FDA has “willfully blinded itself to the warning signs” of prescription painkillers, which have been blamed in part for a spike in opioid-related overdoses and deaths — as many as 47,000 fatalities nationwide in 2014.
Markey wants the agency to convene advisory committees for any opioid-approval questions and to consider the potential for addiction, abuse and dependence when determining which opioids are safe.
Markey also wants the FDA to rescind its approval of OxyContin for children and then convene an advisory panel to provide direction as it reconsiders the decision.
“Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs,” Markey said in a press release.
A spokesman for the U.S. Department of Health and Human Services defended Califf.
“Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market,” department spokesman Kevin Griffis said in a statement.
Griffis said both the department and the FDA have made addressing the opioid crisis a top priority. He said HHS officials will be in touch with the Markey to discuss his concerns.
He also said the FDA’s approval of the use of OxyContin in certain pediatric patients 11 years and older was intended for patients who were already taking opioids and not as a first line treatment, such as when a child has their wisdom teeth out.
Instead the drug is approved for use for children to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment where alternative treatments are inadequate.
Massachusetts officials say they welcome any extra focus on the problem of opioid addiction.
Republican Gov. Charlie Baker, in his state of the state speech last week, criticized what he said was the casual way in which the health care community has dealt with the addictive consequences of opioids.
He echoed those thoughts Monday when asked about Markey’s actions.
“The fact that he has chosen to go this route has generated a ton of news about the issues,” Baker said. “My view is, the more news the better.”
Massachusetts Senate President Stan Rosenberg, a Democrat, said he supports Markey.
“I think the FDA has got to be shaken up a little bit,” he said. “I hope we’ll get a head in there who’ll do some shaking up.”
Massachusetts health officials said there were nearly 1,100 confirmed cases of unintentional opioid overdose deaths in 2014, a 65-percent increase from the 668 confirmed cases in 2012.
