A federal judge struck down the state’s first-of-its-kind emergency ban on Zohydro on Tuesday, saying Massachusetts had no authority to overrule a federal decision to approve the powerful, controversial painkiller.
US District Court Judge Rya W. Zobel said in a five-page ruling that the Food and Drug Administration approved Zohydro after a screening process, in spite of the state’s concerns that it could lead to opiate addictions, and so the state could not enact an outright ban singling out the drug.
“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Zobel said in her ruling, saying the Supremacy Clause of the US Constitution gives the federal regulatory agency more weight than the state.
She also said the state could not force Zohydro’s maker, Zogenix, to make a crush-resistant form of the drug that could not be used by addicts, because that formulation has not been approved by the FDA.
Zobel said in the ruling that Zogenix has “shown injury to its reputation by [the state’s] highly publicized ban of its drug, and the ban also adversely impacts the congressionally-mandated arrangement for ensuring that drugs are safe and effective for those in need.”
Governor Deval Patrick had banned Zohydro after declaring a state of emergency last month to confront the state’s growing epidemic of opiate addiction. The drug is the only analgesic on the market whose sole active ingredient is hydrocodone, and the governor had said that the ban would remain in effect until Zogenix could produce a crush-resistant form of the drug that could not be abused by drug addicts who want to snort or inject it.
In her ruling, Zobel granted a preliminary injunction at the request of Zogenix that overturns the state’s ban pending the final outcome of the case. The judge said her decision was based on the likelihood that the company will prevail in the trial and the immediate harm it was suffering because of the ban, though she stayed her decision until Tuesday.
The stay could give the state time to decide whether to appeal, and give a federal appeals court time to decide whether it would hear an appeal.
Patrick said in a prepared statement that the state would look to other ways to confront the opiate addiction problem.
“I am, of course, disappointed by the court’s decision because it places commercial interests above the public’s health,” the governor said. “Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper-proof.”
Zogenix officials had maintained that they were working on a tamper-resistant form of the drug, but that the FDA had appropriately approved the drug as an around-the-clock treatment that does not contain acetaminophen, which could cause liver failure when taken over a long period of time.
Zobel’s decision “was a positive step forward for Massachusetts patients,” said Roger L. Hawley, Zogenix’s chief executive, in a statement. He said the company invites “concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like [Zohydro] rather than seeking to ban or restrict one specific treatment.”
Support groups for people fighting opiate addiction lambasted Zobel’s decision Tuesday, saying it failed to address their concerns that Zohydro is a painkiller far more powerful than others that is coming on the market as the state is confronting a worsening opiate addiction problem.
They noted that the FDA’s own scientific advisory panel voted against the drug’s approval and that 29 states have asked the federal agency to reverse its decision. US Representative Stephen Lynch has cosponsored a bill that would have the FDA overturn its decision.
“The whole thing is just wrong,” said Joanne Peterson, founder and director of Learn to Cope, a support group for family members and friends of people fighting addiction. “It’s all about the money, and they will make a lot of money on the backs of people’s lives. We’ll go to more funerals, and have to help more people find treatment.”
Leo Beletsky, an associate professor of law and health sciences at Northeastern University, said the support groups have raised notable concerns with the FDA’s decision to approve Zohydro, but he said the state faced an uphill battle in singling out a specific drug under its ban, while failing to prove that the ban on the drug would address the addiction crisis.
He said the drug was being singled out because it is new, but other drugs could lead to the same addiction worries.
“Certainly, there’s a prescription drug issue, and we need to address it, but there’s already an epidemic going on,” Beletsky said. “Zohydro certainly didn’t cause that. Would it make it worse? I don’t know.”Milton J. Valencia can be reached at firstname.lastname@example.org. Follow him on Twitter @miltonvalencia.