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Ban on painkiller Zohydro sparks federal court lawsuit

After Massachusetts Gov. Deval Patrick issued an executive order on March 27 in response to the recent increase in abuse of opioids in Massachusetts, access to some painkillers may be restricted for the Commonwealth’s residents due to a ban on a painkiller called Zohydro ER.

Zogenix Inc., the pharmaceutical company that makes Zohydro, filed a lawsuit Monday in the U.S. District Court against the state of Massachusetts for banning the drug, which is classified as an opioid.

The U.S. Food and Drug Administration approved the painkiller in October 2013, but Patrick’s executive order banned practitioners from prescribing, ordering, dispensing and administering Zohydro.

“I wouldn’t have done it if I didn’t think we had a real emergency, and we have a real emergency,” Patrick said to reporters Tuesday. “Zohydro is not the center of that emergency. It’s an example of highly addictive narcotic painkillers, and it’s one of the few that is not in an abuse-resistant form.”

David Kibbe, the communications director at the Massachusetts Department of Public Health, said Patrick was acting in the interest of Massachusetts residents and aimed to provide a long-term solution to opioid abuse.

“In response to the public health emergency of opioid addiction facing Massachusetts, Patrick took several actions, including the banning of Zohydro, a pure hydrocodone opioid medication, to stop the epidemic from getting worse,” he said in an e-mail. “[He] is also helping those already addicted to recover through additional investments in treatment services, while mapping a long-term solution to ending widespread opioid abuse in the Commonwealth.”

Heather Gray, legislative attorney for National Alliance for Model State Drug Laws, said Massachusetts’ ban on Zohydro makes the state the first in the nation to ban a drug the FDA declared safe for use.

“We have got a lot of questions about it, and in our research in trying to determine what exactly is there any precedent for this, there hasn’t been, so that’s rather unique in this situation,” she said.

Gray said the Zogenix lawsuit could find Patrick’s ban to be unjustified, based on the rights given to states in the constitution.

“States can make laws regarding whatever they want as long they stay within the boundaries of the constitution,” she said. “The question is going to be first whether it runs afoul of the constitution and it likely does. I think what the federal judge is going to find is that it does run afoul of the constitution and there is a less restrictive measure that can be taken to further the goal of preventing prescription drug abuse.”

Leonard Glantz, professor of health law, bioethics and human rights at Boston University, said the ban of Zohydro keeps it from the people who need it.

“Since it has been approved by the FDA, we can say it has been determined to be safe and effective for the conditions it was approved for,” he said. “While we should be careful about opioid abuse, the reason these drugs exist is to keep people from being in pain. That’s what these drugs are used for. The fact that people abuse it does not mean that people who legitimately need it have to be deprived of the drug.”

Several residents said Patrick has a right to do what he feels is best for the Commonwealth, but banning Zohydro may not be beneficial to everyone.

Tony Tran, 30, of Brighton, said there should be more regulation of prescription drugs to protect consumers and decrease cases of abuse and addiction.

“Prescriptions should be more tightly regulated,” he said. “I hear about it all the time in the news, especially with athletes. They have a very addictive quality, so they could do a better job of prescribing them.”

Liu Li, 23, of Kenmore, said the ban on Zohydro should be lifted because there are individuals who rely on the drug to alleviate pain and will not abuse the painkiller.

“It’s [Zohydro] definitely necessary for certain people,” she said. “With different kinds of sickness, people need to relieve pain, and although it’s really easy to get addicted, it certainly is helpful for others who really need it.”

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