Makers of Zohydro File Lawsuit to Lift the State’s Ban on the Prescription Painkiller
Representatives said the Governor enacted the ban without any communication or advanced notice.
A California-based pharmaceutical company filed a complaint in United States District Court in Boston this week, calling for a judge to put a stop to an executive order signed by Governor Deval Patrick that bans doctors statewide from writing prescriptions for their powerful painkiller.
According to a 22-page federal court document, Zogenix Inc., makers of Zohydro ER, an opioid medication, is asking the courts to issue a temporary restraining order and preliminary injunction to block Patrick’s ban of the drug, claiming the governor’s move was “unconstitutional” and will cause irreparable damage to the company’s name and patient care.
“The Commonwealth’s actions are likely to cause physicians, pharmacists, and patients—both in Massachusetts and across the country—to wrongly believe that Zohydro ER is not safe and effective for its intended use,” court documents said.
Packaged inside of a time-release capsule, the potent drug allegedly delivers close to five-times the typical amount of the narcotic hydrocodone than is found in other similar painkillers and medications. It’s not tamper proof, which means it can be crushed and, in essence, easily abused, state officials claim.
Despite its powerful effects and concerns expressed by Patrick, Zogenix representatives said that the FDA already legally approved Zohydro last October. The company argued in court documents that the prescription and distribution stoppage in Massachusetts directly conflicts with the FDA’s decision that the drug is “safe and effective” for patient use. “[The] FDA, not [Governor Patrick and the Department of Public Health], has the authority to approve new drugs, to determine the formulations that are safe and effective for use, and to authorize their introduction into the interstate market,” the court filing said. The legal action comes after a formal written request to the Governor for a meeting to discuss the facts about the product “went unanswered,” the company said. Zogenix has spent $75 million since 2007 on research and development of the drug before making it available to the general public.
In late March, while declaring a public health emergency in response to the rising opiate and heroin addiction and overdose problems that continue to plague the Bay State, Patrick said that Zohydro wouldn’t be available in Massachusetts until it was produced in an abuse-deterrent form. He urged lawmakers at a federal level to support his ban on the drug, citing its potential to add to the rise in drug-related fatalities. “Zohydro is a dangerously addictive pharmaceutical painkiller approved by the FDA recently,” Patrick said. “[It] is a potentially lethal narcotic painkiller, depending on whether or not it’s ingested quickly [or] swallowed right away.”
Makers of the drug have disputed claims about its potency.
Zogenix representatives said Patrick’s decision was taken without any communication or advanced notice, however, blindsiding the drug manufacturer. “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,” said Roger Hawley, chief executive officer of Zogenix.
But Patrick isn’t the only one worried about the potential impacts Zohydro could have on the community. In a similar move, Vermont Governor Peter Shumlin announced an emergency order make it harder for doctors to prescribe Zohydro, according to reports. Shumlin told reporters that Zohydro “has been approved by the FDA to the bewilderment of many of us.”
Zogenix representatives said the harm to the state officials’ reputations if they reverse the ban pales in comparison to the problems the company will face if doctors are not allowed to prescribe the medication due to claims that the medication is unsafe. “The only harm to defendants would be the de minimis cost of communicating with providers throughout the state that they may prescribe Zohydro ER once again. Defendants quickly communicated the ban; they will be able to just as quickly communicate its lifting,” according to court documents. Zogenix said they are sympathetic to the concerns about the possibility of additional opiate abuse in Massachusetts, but cutting off the supply to patients in need isn’t the right way to stop the problem.
Governor Patrick’s office was not immediately available for comment about the pending litigation.
Source URL: http://www.bostonmagazine.com/news/blog/2014/04/08/zohydro-er-court-boston-ban/