A federal judge in Boston has ruled that an unprecedented ban on the sale of a controversial new painkiller in Massachusetts is unconstitutional. Despite the ruling, Zohydro is likely to remain very hard to obtain because of precautions taken by physicians, health insurers and pharmacies.
U.S. District Judge Rya Zobel said an emergency order by Massachusetts Gov. Deval Patrick that prohibits the prescribing or dispensing of Zohydro interfered with the authority of the Food and Drug Administration to regulate prescription drugs.
“The Commonwealth’s emergency order thus stands in the way of ‘the accomplishment and execution of’ an important federal objective. The Constitution does not allow it to do so,” Judge Zobel wrote in her decision.
“The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”
Judge Zobel stayed her own order until April 22. Gov. Patrick told reporters on Wednesday that his administration was unlikely to appeal the ruling.
Last month Gov. Patrick declared a public health emergency in Massachusetts over the “opioid addiction epidemic” and ordered the ban on Zohydro ER, the first FDA-approved extended release hydrocodone product that does not contain acetaminophen. Some addiction treatment experts have claimed the new painkiller – which does not come in an abuse deterrent formula — will fuel a new wave of narcotic addiction and overdoses.
“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,” Zobel said.
San Diego-based Zogenix (NASDAQ:ZGNX), which makes Zohydro, praised the Judge’s ruling.
“The court decision today supports the importance of upholding the Constitutional principle at the heart of this case,” the company said in a statement.
“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.”
In recent months, addiction treatment experts, several congressmen and the attorneys general from 28 states have asked the FDA to reconsider its decision to approve Zohydro, claiming the painkiller was several times more potent than other hydrocodone drugs such as Vicodin.
CVS Policy for Dispensing Zohydro
Even with FDA approval, getting Zohydro won’t be easy for pain patients because of restrictions placed on the drug by many pharmacies.
In an 11-page memo obtained by National Pain Report that CVS sent to its pharmacists, the drug store chain outlined a series of elaborate steps that every CVS pharmacy will have to follow before dispensing Zohydro.
“It is anticipated that Zohydro ER, as a single ingredient hydrocodone product, will be highly sought after by drug abusers,” the CVS memo states. “There is significant concern in the community about the potential for the misuse and abuse of this product as it does not contain any abuse deterrent technology.”
Each Zohydro prescription will be placed on an automatic hold by CVS until the prescribing physician is contacted and asked to fill out a form. When completed, that form must then be reviewed at a CVS Retail Pharmacy Call Center. The certification process “may take 3 to 5 days” or possibly even longer, according to the memo.
CVS pharmacists will only be permitted to order Zohydro once the certification process is complete. Pharmacists must restrict their orders to “the minimum quantity necessary” to fill the prescription, according to the memo, and CVS will monitor the orders to ensure that no pharmacy builds up an inventory of Zohydro.
“If you at any time have reason to believe the prescription was not obtained or written for a legitimate medical purpose you must refuse to fill,” the memo warns pharmacists.
CVS, Walgreens and other drug store chains tightened their policies for filling all opioid prescriptions after being fined tens of millions of dollars by the DEA for violating rules and regulations for dispensing controlled substances.
CVS could face additional fines for allegedly losing track of 37,000 prescription painkillers at four of its California stores. Many of the drugs may have been sold on the black market.