A coalition of addiction experts and anti-opioid activists is calling on the Obama administration to fire Food and Drug Administration Commissioner Dr. Margaret Hamburg, saying “without new leadership at FDA the opioid crisis will continue unabated.”
In a letter addressed to Health and Human Services Secretary Sylvia Burwell, the group criticized the FDA’s approval nearly one year ago of Zohydro, a controversial opioid painkiller, as well as a recent decision to approve another extended-release opioid called Targiniq, which combines oxycodone with an abuse deterrent formula.
“We are especially frustrated by the Food and Drug Administration’s (FDA) continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letters states.
“We are urging you to intervene. Pleas from across the country for FDA to respond to the opioid crisis by properly exercising its authority and responsibility have fallen on deaf ears for too long. We urge you to seek new leadership for FDA; leadership that will work in a coordinated fashion with the CDC and other federal and state agencies, leadership willing to re-examine past decisions, and leadership that will consistently put the public’s health ahead of industry interests.”
The letter is signed by Andrew Kolodny, MD, President of Physicians for Responsible Opioid Prescribing (PROP), as well as 17 other addiction experts and anti-opioid activists. One politician, Rep. Gene DiGirolamo (R-PA), Chairman of the House Human Services Committee, also signed the letter, which appeared to be timed to promote a rally against prescription drug abuse this Saturday, September 28th, on the National Mall.
“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter,” said Tait Sye, a spokeswoman for Burwell.
A spokeswoman for the FDA called Hamburg, who has led the agency since 2009, “a tireless public health advocate.”
“Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA,” said Erica Jefferson in a statement.
Hamburg has been a stout defender of the FDA’s decision to approve Zohydro, the first “pure” hydrocodone painkiller.
In April, Hamburg said Zohydro was no more powerful or addictive than other opioid medications and pain patients should have access to it.
“Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine,” said Hamburg in a blog on the FDA website.
Some addiction treatment experts predicted Zohydro – which does not come in an abuse deterrent formula — would fuel a new wave of narcotic addiction and overdoses.
Since months after its introduction, however, there have been no confirmed cases of diversion, overdose or death caused by Zohydro, according to the chief medical officer of Zogenix, the San Diego-based company which makes the drug.
“We’re very, very happy with the data that we’re seeing. We haven’t publicly disclosed it, but we’re extremely happy,” said Bradley Galer, MD, told National Pain Report. “We’re not aware of any diversion. Is it out there? I don’t know. But we’re not aware of any at all.”