The tussle over the appropriateness of the newly available potent painkiller Zohydro has moved to the courts. San Diego-based drug manufacturer Zogenix, Inc., on April 7 filed a federal lawsuit to block an executive order issued by Massachusetts Gov. Deval Patrick that prohibits that state's physicians from prescribing and dispensing the medication.
Zogenix is asking the U.S. District Court in Massachusetts to grant a temporary restraining order against execution of the governor's order, which it says interferes with the Food and Drug Administration's (FDA's) authority to determine drug safety and impose measures to protect patients.
Zogenix CEO Roger Hawley said in a news release, “Governor Patrick's unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data.”
Zohydro is intended for use in managing pain so severe that around-the-clock treatment is needed and no other available treatments are adequate. But numerous health professionals and policy-makers believe the FDA erred in approving the drug at a time when much of the nation is in the grip of an opioid addiction crisis. Other government leaders besides Patrick have moved to restrict physicians' use of the medication.