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In December 2012, the FDA Analgesic and Anesthetic Advisory Committee advised against the approval of Zohydro, a hydrocodone painkiller without a mechanism to deter abuse. "The entire class is problematic in terms of abuse and safety issues," explained Jim Ware, Harvard School of Public Health professor and advisory committee member.
One year later, the FDA approved Zohydro. As an opioid medication without an anti-abuse mechanism, Zohydro is classified as Schedule II, which means that it can only be dispensed with a doctor's written prescription and cannot be refilled. However, the FDA was sufficiently concerned about abuse of the drug to require post-marketing surveillance to gather data on adverse events such as dependency and death. This seems a prudent move, given that evidence for the drug's safety rests on 1,148 patients, only 285 of whom were followed for more than one year.
Last week, the governor of Massachusetts declared that post-marketing surveillance is not enough to protect the citizens of Massachusetts. Invoking his ability to declare a state of public health emergency, Governor Deval Patrick banned the prescribing of Zohydro, as well as the filling of Zohydro prescriptions, throughout the state of Massachusetts. The painkiller's manufacturer, Zogenix, was quick to complain about the governor's actions, asserting that the state of Massachusetts is "den[ying] patients a legitimate option for severe chronic pain." In a surprising move, the FDA followed suit, telling the media that the ban is "extremely troubling." The FDA's opposition to Governor Patrick's actions does not appear to stem from concerns about interstate commerce, as the agency also decried "efforts by Congress [...] to legislate the approval or marketing withdrawal of medications."
Indeed, the FDA appears to believe that Americans do not have enough access to strong painkilling drugs, despite reports that:
- One in seven pregnant women has been given a prescription for an opioid during her pregnancy;
- Nearly 50 percent of adolescents who visit a doctor for a headache end up with a prescription for narcotics;
- Twenty-seven percent of Americans who use opioids for non-medical indications 200 or more days per year have been prescribed these drugs by a doctor;
- Zohydro is five to ten times more powerful than other hydrocodone drugs, and can be crushed and abused.
The FDA approval of Zohydro over the advisory committee's 11 to 2 recommendation for denial, as well as the FDA statements in defense of Zogenix, may come as a surprise -- unless one has read the reports from Public Citizen and the Milwaukee Journal-Sentinel regarding wooing of FDA officials by painkiller manufacturers. According to reporter John Fauber, painkiller manufacturers pay as much as $35,000 each year to send a representative to meet with FDA officials (and officials from the European Medicines Agency) at swanky hotels. These meetings are hosted by an industry group known as IMMPACT. It is interesting to note that Bob Rappaport, head of the Division of Anesthesia Products, Analgesia Products, and Addiction Products -- the man who oversaw the approval of Zohydro -- has attended every IMMPACT meeting except IMMPACT VI.
The next IMMPACT meeting will take place April 17th and 18th in Washington, DC.