The company that makes Zohydro is suing the state of Massachusetts for blocking sales of the controversial prescription drug, even after the Food and Drug Administration (FDA) last year approved it for use by patients with severe chronic pain.
The San Diego-based Zogenix filed a lawsuit in the U.S. District Court in Massachusetts on Monday, seeking an injunction against Gov. Deval Patrick's executive order banning doctors from prescribing Zohydro in his state.
"Governor Patrick's unilateral action was taken without any communication or advance notice," Zogenix CEO Roger Hawley said in a statement. "In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order.
"Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data," he added. "This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simple should not be usurped by individual states."
This comes after Patrick (D) last month banned doctors in his state from prescribing and pharmacies from dispensing Zohydro, following a string of criticisms from lawmakers over the FDA's approval of the painkiller.
"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.
Critics say the prescription drug is highly addictive and easily abused.
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 SebeliusKathleen SebeliusSebelius on GOP healthcare plan: 'I'm not sure what the goal is here' Obama's health secretary to be first female president of American University Leaked email: Podesta pushed Tom Steyer for Obama’s Cabinet MORE, 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.
Before filing the lawsuit, Zogenix requested a meeting with Gov. Patrick, but received no response from his office, the company said.
"The suit argues that this decisions is in direct conflict with the authority of the FDA to determine on behalf of the public whether a drug is safe and effective, and to impose the measures necessary to ensure that the drug will be used safely and appropriately," the company said.