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From Health Law Daily, April 10, 2014

Massachusetts governor declares “epidemic of opiate abuse,” bans Zohydro™ ER

By Greg Hammond, JD

Pharmaceutical company Zogenix, Inc. filed suit on April 7, 2014, seeking to set aside the Governor of Massachusetts’ emergency declaration that immediately prohibited the prescribing and dispensing of Zogenix’s prescription drug, Zohydro™ ER (Zohydro). The drug, which is the only hydrocodone product that is currently subject to Schedule II controls by the Drug Enforcement Administration, is used to treat patients that require around-the-clock, long-term opioid treatment for severe pain and for which there are no adequate alternative treatment options available.

Health crisis. Massachusetts Governor Patrick issued an emergency declaration on March 27, 2014, in response to a growing opioid addiction problem within the state. The governor stated, “We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is. I have directed DPH to take certain immediate actions and to give me further actionable recommendations within 60 days, to address this challenge and better protect the health of people suffering from addiction and the families and loved ones who suffer with them.” Some of the immediate actions the declaration provided for included: (1) allowing first responders to carry and administer the opioid antagonist, Naloxone, which can effectively reverse opioid overdose; (2) mandating physician and pharmacy prescription monitoring in order to safeguard against opioid abuse or misuse; and (3) the immediate prohibition of Zohydro.

Legal action. According to Zogenix chief executive officer Roger Hawley, “Governor Patrick’s unilateral action was taken without any communication or advanced notice,” he stated in a company news release. “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. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order,” he said.

In addition to filing its complaint for permanent injunctive relief and declaratory judgment, Zogenix also filed a motion for temporary restraining order and preliminary injunction, noting that the company will suffer irreparable harm to its reputation and goodwill if the ban is not stayed. The company’s memorandum in support of its motion stated that the governor’s emergency declaration banning Zohydro is preempted by the FDA’s determination that the product is safe and effective and may be sold in the U.S.

“Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data,” stated Hawley. “This rigorous FDA review process serves the nation’s public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states.”

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