Judge blocks ban on FDA-approved painkiller

 

Massachusetts will be required to allow sales of a controversial prescription drug, after a federal court on Tuesday overturned an in-state ban of the FDA-approved painkiller Zohydro.

The federal judge ruled that the Food and Drug Administration (FDA) has the final say on whether to approve medicine, in a case that pitted states' rights against the authority of the federal government to regulate.

Massachusetts Gov. Deval Patrick (D) banned Zohydro late last month, arguing that the prescription drug endangers citizens in his state, because it is highly addictive and easily abused. But the judge decided that the state's authority in this matter does not supersede that of the federal government's. 

"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," Judge Rya Zobel said in the ruling. "For the same reason, the injunction is in the public interest."

The drugmaker Zogenix, which challenged the state's ban last week in the U.S. District Court in Massachusetts, said Tuesday it was pleased with the judge's decision.

"Allowing states to overturn the decisions of medical and scientific professionals at the FDA, which is the federal agency Congress has authorized to regulate matters involving patient safety and the effectiveness of medications, would set an alarming precedent with respect to the federal regulation of access to new prescription medications," the company said in a statement.

Patrick banned Zohydro after widespread criticisms about the potential for misuse and abuse that it poses for addicts.

"Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council, and is not available in an abuse-deterrent form," Patrick said in a speech announcing the ban.

"Until it is available in an abuse-deterrent form, or better, until the secretary of [Health and Human Services] or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts," he said.

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain. Other combination drugs mix hydrocodone with weaker, nonaddictive painkillers like aspirin to balance out the effects.

The FDA approved the painkiller last October, despite warnings from the agency's own experts that it poses a danger to society.

Since then, a number of lawmakers have written letters to FDA Commissioner Margaret Hamburg, requesting that she reverse the agency's decision. Some also asked Health and Human Services Secretary Kathleen Sebelius, who oversees the FDA, to go over Hamburg's head.

Still, other lawmakers are working on legislation that would force the FDA to withdraw approval of Zohydro.

The judge's temporary order is stayed until April 22.

“The FDA endorsed Zohydro ER’s safety and effectiveness when it approved the drug," Zobel said. "When (Massachusetts) interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of DPH’s emergency order, did it obstruct the FDA’s congressionally given charge? I conclude that it did."