A lawyer for Massachusetts urged a federal judge Monday to uphold the state’s emergency ban on Zohydro, a powerful, controversial painkiller, saying the state has the authority to regulate drugs coming into its market to confront a growing opiate addiction epidemic.
No other state is believed to have banned a drug that has been approved by the US Food and Drug Administration, the federal regulatory agency.
But Assistant Attorney General Jo Ann Shotwell Kaplan argued that this is an unusual case, in which the FDA has approved a drug that has been opposed by 29 states. The FDA’s own scientific advisory panel voted 11 to 2 against the drug’s approval, she said.
“A majority of the states weighed in on this and said, ‘Don’t approve this,’” said Kaplan, adding that “for that combination of states to coalesce is fairly unusual.”
“I think you’re seeing a case that has not been brought before, and I think this is why you’re seeing it,” Kaplan said.
Steven P. Hollman — a lawyer for the drug’s maker, Zogenix — argued that the state cannot put new restrictions on a drug that has already been approved by the federal agency responsible for making that decision.
“Congress’s intent was clear: It directed the FDA to promote public health by exclusively approving safe and effective drugs,” Hollman said during a brief hearing Monday morning.
The company has filed a lawsuit against the state, contending that the ban violates its constitutional rights, and it has sought a preliminary injunction that would vacate the ban until the full lawsuit plays out.
US District Court Judge Rya W. Zobel said at the end of the hearing that she would consider the issue, but did not say when she might make a decision. She must weigh whether the company has a likelihood of success and whether the company would be significantly harmed if the ban is not immediately lifted. After a brief hearing last week, she suggested that Zogenix would probably prevail, but she seemed to be giving the arguments a closer look Monday.
In declaring a state of emergency in late March that was aimed at confronting the burgeoning opiate overdose crisis, Governor Deval Patrick banned the prescription and sale of hydrocone-only drugs, a category that includes only Zohydro. Patrick said the ban would remain until proper safeguards are put in place, such as making the drug crush-resistant, so it could not be snorted or injected by addicts.
Hollman argued that Congress never intended to allow states to further regulate drugs; in that case, the company could have to cater to each state’s regulations, creating “too many safety standard ‘cooks.’ ”
But Kaplan argued that the FDA’s approval created a floor standard, not the ceiling, and that the state could go further. She said that all Zogenix would have to do is make the drug tamper-proof and then clear that version of the drug with the FDA.
“The harm to the public outweighs the harm to a single company,” Kaplan argued.
The drug has not been sold in the state, though four prescriptions had been written before the ban went in effect.
Zogenix officials have defended the drug, saying it has already undergone a strict 18-month screening process and was approved with tighter oversight than other drugs, such as Vicodin. He argued that the drug was made to be safer than other painkillers that contain acetaminophen, because it avoids the potential for toxic doses of acetaminophen over a long period, which can cause liver damage and liver failure.
Vermont officials enacted regulations last month that would make it tougher to prescribe the painkiller. Federal officials, including US Representative Stephen Lynch, have asked the FDA to overturn its approval of the drug.
Zogenix officials also say that they are in the early stages of developing tamper-proof formulations of Zohydro and that they took the extraordinary step of assembling an oversight board to monitor its use. They stressed, however, that the FDA had already considered those factors in approving the drug.
After Monday’s hearing, representatives from the support group Learn to Cope confronted Stephen J. Farr, president of the California-based Zogenix, in the courtroom and asked him to reconsider the sale of Zohydro, which opponents argue can come in doses five times as strong as Vicodin, making it more susceptible to abuse and addiction.
“This is a problem, an epidemic,” said Michelle Grover, a South Shore resident, who said her 24-year-old son is fighting an opiate addiction. “Some of our friends have actually lost children.”
Farr told several women from the group, who wore matching T-shirts promoting the support group, that the company ensures that “our products are as safe as can be.”Milton J. Valencia can be reached at mvalencia@