U.S. District Court Suspends Massachusetts' Zohydro Ban

A U.S. District court issued a ruling that a Massachusetts ban on Zohydro, an opioid pain reliever, is unconstitutional. Last year, the Food and Drug Administration (FDA) approved the controversial drug amid its own efforts to curb opioid drug abuse. Experts, law enforcement officials, and state governments protested the approval but the FDA stood fast, saying that the benefits outweighed the risks. Massachusetts Governor Deval Patrick, concerned about the drug’s ability to be snorted and crushed or otherwise abused, took the matter into his own hands. He announced that Zohydro ER was a threat to public health, declared an emergency situation, and issued a statewide ban on Zohydro on March 27, 2014.

Zogenix, Zohydro’s manufacturer, responded to the ban by filing suit in federal court. The company sought an injunction against the ban, citing states’ position as inferior to federal law because the FDA is a federal agency responsible for approving or disapproving drugs. According to Zogenix, Massachusetts has no right to obstruct the FDA.

U.S. District Court Action

The court agreed, saying that obstructing the FDA’s mission to improve health by banning Zohydro would unfairly burden people in legitimate need of the drug. In the decision, Honorable Rya Weickert Zobel, a Senior United States District Court Judge on the United States District Court for the District of Massachusetts, said that she gained the facts from the verified complaint and the parties’ affidavits.

She acknowledged that Zohydro ER does not have an abuse-resistant formulation, making it easier to crush, inhale, or inject, and the lack of the abuse-resistant formulation has caused concern, especially in Massachusetts with its recent spike in opioid overdoses. The judge stated that for Zogenix to succeed with its three-count complaint and preliminary injunction, it must be able to establish the following.

• It is likely to succeed on the merits
• It is likely to suffer irreparable harm in the absence of preliminary injunctive relief
• The balance of equities weighs in its favor  
• An injunction is in the public interest

The judge determined that those conditions were met. She went on to address Zogenix’s main argument that the ban was unconstitutional. She wrote, “When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of DPH’s emergency order, did it obstruct the FDA’s Congressionally-given charge? I conclude that it did.”  

Following this ruling, some drug companies may feel safer that state governors cannot overrule the FDA. However, other companies, in the midst of increasing concerns about opioid addiction, may also choose to begin formulating new drugs with abuse-resistant formulations.