Advocacy groups, including National Coalition Against Prescription Drug Abuse, and the FED UP Coalition, this week sent a letter to a top federal official that called for the resignation of FDA Commissioner Margaret Hamburg, noting that she has allowed the approval of new opioid drugs that pose addiction risks. It’s a complaint that’s been going on for months. Hamburg insists that such drugs are needed for those who have chronic pain.
In the letter to the Secretary of Department of Health and Human Services Sylvia Burwell, the groups state:
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.
In October 2013, the approval of Zohydro ER (hydrocodone bitartrate extended release) outraged many in the recovery community. The drug is the first approved single entity hydrocodone medication and the first with an extended release formulation. It does not have abuse-deterrent properties. Even FDA’s own advisory panel voted 11 to 2 against approving it, saying it could become the abuser’s drug of choice. Since the approval of the extended release formulation—which contains up to five times the amount of hydrocodone of the standard medication—several governors have written letters asking FDA to reverse its approval decision, noting the severe addiction problems already plaguing their states.
In a letter responding to industry concerns about Zohydro, FDA’s Center for Drug Evaluation and Research indicated that it believes the benefits of the drug outweigh the risks.
The approval of Targiniq (oxycodone and naloxone) this past July also provoked concern. Although the drug has naloxone to deter abuse, the drug can still be abused by chewing the tablets.
Health advocates are planning a rally to march to the White House on September 28, 2014, at 1 p.m., to call for more federal action to end addiction and overdose deaths.