Judge: Patrick’s drug ban may be ‘out of line’
A federal judge on Tuesday cast serious doubt on Gov. Deval Patrick's aggressive move to ban a powerful new painkiller from being prescribed in Massachusetts, giving the administration and the drug's manufacturer until next week to resolve the dispute before she issues a ruling.
Zogenix, the maker of Zohydro, filed for an injunction in U.S. District Court seeking to halt the Patrick administration's ban on the prescribing of any hydrocodone-only painkiller, which the governor said posed a "significant risk to individuals already addicted to opiates and to the public at large."
The drug, which won approval from the Food and Drug Administration in October, hit the market last month over the objections of some public health authorities who worried about its potency and potential to be abused.
U.S. District Court Judge Rya Zobel did not rule on the ban, but said she thought Patrick may have been "out of line" in banning Zohydro, which is an FDA-approved drug, according to The Associated Press. Zobel said she would hear arguments Monday at follow-up hearing before ruling on the temporary stay.
Patrick, who banned Zohydro in late March as part of an executive order declaring a public health emergency around opioid addiction, said the order would last until the drug could be manufactured in an abuse-resistant form or until Congress acted on requests to overturn the FDA's approval. Other states like Vermont have taken or are considering less drastic steps, such as making Zohydro more difficult to prescribe by requiring more through risk evaluations.
"We do have that authority," Department of Public Health Commissioner Cheryl Bartlett told reporters on Tuesday. Bartlett said Patrick's declaration of a public health emergency, a response to the state's opiate addiction problem, enabled DPH to take the action it did.
Zogenix President Stephen Farr said, "We appreciate the fact that the judge is hearing this important case on an expedited basis and wants to resolve it as swiftly as possible in a manner that is fair and just. We are eager to ensure that patients suffering from severe chronic pain have access to this much-needed prescription medication."
Between 2000 and 2012 there has been a 90 percent increase in unintentional deaths from opiate overdoses, and there was a 10 percent increase from 2011 to 2012, Bartlett told a group of local officials gathered in the State House Tuesday afternoon. She said the abuse is occurring among young people, with about 44 percent of the cases occurring in people between the ages of 13 and 29.
Heroin is a cheaper opiate than prescription opiates such as Oxycontin, and many people fall into addiction by taking prescription pills, Bartlett said. Heroin makes addicts of about 23 percent of people who experiment with it, and about 80 percent of people who are addicted to opiates struggle with the addiction their whole lives, Bartlett said.
"This is an emergency," said Bartlett.
Dr. Bradley Galer, the chief medical officer at Zogenix Inc., said it is "unprecedented territory" for a state to ban an FDA-approved drug. "We do not believe Massachusetts, or any state, has the right to single out any one medication," he said.
Zogenix executives had "absolutely no warning" the governor was considering prohibiting doctors and pharmacists from distributing the medication, and only found out through the company's hourly Google news search, Galer said.
Though other drugs such as Oxycontin that are still available with prescriptions and can be abused, Bartlett said the singling out of Zohydro had to do with its newness to the market as well as its risk.
"I think they're both very dangerous," Bartlett said. "But they're already on the market. People are using those. If we banned them now we would be taking that away from people."
Bartlett said the state had considered other alternatives to banning the painkiller, and decided to issue a ban before use of the drug became more prevalent.
The active opioid medication in both Vicodine and Zohydro is the same, hydrocodone, according to Galer. He said one of the misconceptions about Zohydro is that it is more potent than other opioid pain relievers. "Our tablet strengths go from 10 milligrams to 50 milligrams," he said.
In addition, Zohydro is an extended-release pain medication that patients take every 12 hours, as opposed to every four to six hours, according to Galer.
"When politicians play doctor, patients lose," Galer said. "This is between a health care prescriber and his or her patient."
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