A federal judge has blocked Massachusetts from banning the powerful new painkiller Zohydro.U.S. District Court Judge Rya Zobel on Tuesday issued a preliminary injunction after the maker of the drug, Zogenix, argued in a lawsuit that the ban ordered by Gov. Deval Patrick last month is unconstitutional.
Zobel said in issuing the injunction that Massachusetts appears to have overstepped its authority in banning the prescription medication, which had been approved by the federal Food and Drug Administration, and that Zogenix was likely to succeed in its pursuit of a court order to lift the ban permanently.
The San Diego-based drugmaker hailed the ruling, saying that allowing states to essentially overturn decisions of the FDA would “set an alarming precedent.”
Patrick said he was disappointed, arguing that the ruling places commercial interests above the public’s health.
“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,” Patrick said in a statement. “We will turn our attention now to other means to address this public health crisis.”
The ban is believed to be the first attempt by a state to block a federally approved drug, according to the National Alliance for Model State Drug Laws.
Patrick ordered the ban after declaring a public health emergency in light of a surge of drug overdoses and overdose deaths in the state. The state argued that Zohydro would “exacerbate a severe public health crisis” because the narcotic can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.
In her decision, Zobel noted the FDA’s approval of the drug in October and said federal law pre-empts Patrick’s emergency order.
“When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of the … emergency order, did it obstruct FDA’s Congressionally-given charge? I conclude that it did,” Zobel wrote.
She said allowing the ban would “undermine the FDA’s ability to make drugs available to promote and protect the public health.” She said Patrick’s suggestion that the ban might be lifted if Zogenix created a non-crushable “abuse-resistant” version of the prescription medication would force Zogenix to return to the FDA to seek approval for a drug different from the one that the FDA has already deemed safe.
Zogenix has also been able to show injury to its reputation by the highly publicized ban, Zobel said.
The judge said the state’s concerns can’t trump the legitimate use of the drug.
“Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers,” she wrote.
Roger Hawley, chief executive officer of Zogenix, called the decision “a positive step forward for Massachusetts patients.”
“We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment,” Hawley said in a written statement.
Lawyers for the state had argued that the Massachusetts ban wouldn’t affect the federal approval process or the company’s ability to sell the drug elsewhere in the United States, but simply represented “another hurdle” the company must surpass in order to market the drug in Massachusetts.
Date: April 15, 2014
Source: Associated Press
Filed Under: Drug Discovery
