An unprecedented ban on a controversial new painkiller remains in effect in Massachusetts, after a federal judge in Boston heard arguments in a lawsuit by drug maker Zogenix (NYSE:ZGNX) asking for a temporary restraining order that would allow Zohydro to be prescribed and dispensed in the state.
There was no indication when federal Judge Rya Zobel would rule on the case. Last week Zobel indicated she might overturn the ban, saying,“I think that, frankly, the governor is out of line on this.”
Last month Gov. Deval Patrick declared a public health emergency in Massachusetts over the “growing opioid addiction epidemic” and ordered the ban on Zohydro, the first pure hydrocodone painkiller sold in the U.S. Some addiction treatment experts have claimed the new painkiller will fuel a new wave of narcotic abuse and overdoses.
“Imagine 50 states each imposing a different formulation requirement,” Zogenix attorney Stephen Hollman said during a brief hearing Monday, arguing that individual states do not have the authority to restrict a drug approved by the Food and Drug Administration.
“Congress’ intent was clear. It directed the FDA to promote public health by exclusively approving safe and effective drugs,” Hollman said.
Massachusetts Assistant Attorney General Jo Ann Shotwell Kaplan said states do have the right to regulate drugs and said FDA approval is “not a guarantee that they get to market thereafter in every state.”
Kaplan said she was not aware of any other state banning an FDA approved drug, but said the Zohydro case was unusual because the agency approved Zohydro over the objections of its own staff and advisory committee, which warned the painkiller could be abused even more than currently available hydrocodone products.
In recent months, addiction treatment experts, several congressmen and the attorneys general from 29 states have asked the FDA to reconsider its decision to approve Zohydro, claiming the painkiller was several times more potent than other hydrocodone drugs.
The American Academy of Pain Management (AAPM), which represents over 4,300 healthcare providers in the field of pain management, released a statement in support of Zohydro, saying there was “hysteria over its abuse potential”.
“The Academy believes that banning Zohydro is not the right solution. Doing so would unfairly penalize the vast majority of individuals for whom it would be prescribed, in the service of protecting those relative few who would choose to use it inappropriately,” the AAPM said in the statement.
“We recognize the likelihood that Zohydro will be misused, abused, and/or diverted by individuals whose motives are other than the intended use of the product. In this sense, it is no different than any other opioid analgesic, immediate release or extended release, on the market.”