A Judge Ruled the State Can’t Ban Prescription Drug Zohydro

The FDA's choice to allow the sale of the pills trumps Massachusetts' attempt to keep them out of people's hands.

After a brief battle in court this week, a federal judge ruled Tuesday that state officials don’t have the legal muscle to stop doctors from prescribing a powerful prescription painkiller called Zohydro, since it’s already been approved for use and sale by the Federal Drug Administration.

Citing the fact that the administration has federal jurisdiction over such decisions, U.S. District Court Judge Rya Zobel said Governor Deval Patrick’s arguments in support of an emergency order for a statewide ban on Zohydro, an opiate produced by California-based Zogenix, Inc. that’s used to treat chronic pain in patients, is without merit. “Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers,” the judge wrote in a five-page filing submitted Tuesday. “I conclude that the Commonwealth’s emergency order is preempted by federal law.”

The order goes into effect on April 22.

Last week, the makers of Zohydro filed a three-count complaint in federal court alleging that Patrick’s ploy to unfurl an emergency order banning the prescription, ordering, dispensing, and administration of the controversial drug was unconstitutional. The company argued that the proposed ban, declared by Patrick during a press conference addressing the heroin and opiate epidemic plaguing the state, also shed a negative light on Zogenix’s research and standing in the medical community. After Patrick enacted the ban, the company immediately filed for a temporary restraining order and preliminary injunction to block Patrick’s actions. “The Commonwealth’s actions are likely to cause physicians, pharmacists, and patients—both in Massachusetts and across the country—to wrongly believe that Zohydro ER is not safe and effective for its intended use,” the company said in court documents.

Packaged inside of a time-release capsule, the potent drug allegedly delivers close to five-times the typical amount of the narcotic hydrocodone than is found in other similar painkillers and medications. It’s not tamper proof, which means it can be crushed and, in essence, easily abused, state officials said when calling for the ban.

“Because Zohydro does not have an ‘abuse-resistant formulation,’ it can be crushed and inhaled or injected, making the full dose of the hydrocodone available immediately,” Zobel wrote Tuesday, adding that the state’s concern was especially potent given the recent spike in opioid-and-heroin-related deaths in Massachusetts. But that didn’t stop the judge from allowing the injunction.

“The FDA endorsed Zohydro ER’s safety and effectiveness when it approved the drug. 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,” Zobel said.

During a court hearing yesterday, prior to the judge’s decision, family members of drug addicts that are part of a group called “Learn to Cope” rallied in support of Patrick’s ban. “LTC mothers and fathers will never stop fighting the good fight because of what they have been through and in the hopes other families won’t,” they wrote on their Facebook page at  the time. 

Patrick did  not immediately respond to the court’s decision, but the makers of the drug applauded the court for upholding Constitutional principles. “Today’s legal ruling was a positive step forward for Massachusetts patients,” stated Roger Hawley, chief executive officer of Zogenix. “We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment.”