US District Court Overturns Zohydro Ban in Massachusetts

Susan Jeffrey

April 16, 2014

Zogenix Inc has won a preliminary injunction against the Commonwealth of Massachusetts that overturns a ban in that state on the prescription and dispensing of Zohydro ER, a single-entity extended-release hydrocodone analgesic, on constitutional grounds.

"Because I conclude that the Commonwealth's emergency order is pre-empted by federal law, plaintiff's motion is allowed," US District Judge Rya W. Zobel concludes in her decision.

On March 27, Governor Deval Patrick declared a public health emergency and directed the Department of Public Health (DPH) to take steps to reduce opioid addiction in the state. Among the measures was an emergency order by DPH Commissioner Cheryl Bartlett to prohibit prescribing and dispensing of Zohydro ER until adequate measures to protect against diversion, overdose, and misuse had been implemented.

Judge Zobel noted that the US Food and Drug Administration (FDA) endorsed the safety and effectiveness of Zohydro ER when it approved the drug. "When the Commonwealth 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," she writes.

"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."

The decision is stayed until April 22, when it will become effective.

FDA Responds

In a statement, the FDA responded to this latest development.

"The FDA is following the legal proceedings in Massachusetts with great interest, and we remain concerned about efforts by States to ban FDA-approved drugs," the statement notes. "Both the prevention of prescription opioid abuse and appropriate pain management are top public health priorities at FDA. 

"Actions to advance one should not impede the other, and the agency will continue to balance our efforts and apply sound science as we move forward," the agency adds. "The FDA makes its approval decisions based on science and by carefully evaluating the safety and effectiveness of every pain medication. In the case of Zohydro ER, we determined that the benefits of the product outweigh its risks."

In a statement of its own, Zogenix Inc said the court decision "supports the importance of upholding the Constitutional principle at the heart of this case." The FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate, the company notes.

"This approval was based on a thorough review of the safety and effectiveness data in support of Zohydro ER," the statement said. "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. After careful consideration, the District Court agreed."

"Today's legal ruling was a positive step forward for Massachusetts patients," Roger Hawley, chief executive officer of Zogenix, notes in the statement. "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."

"Zogenix will continue to work to ensure patients suffering from severe chronic pain have access to the FDA approved medications they need in every state nationwide," the statement concludes. There have been moves to limit use of Zohydro ER in other states, including Vermont.

The suit in Massachusetts is the latest development in a saga that began when the FDA approved Zohydro ER, which doesn't have abuse-deterrent technology, even though the FDA's own advisory panel recommended against approving the drug in an 11 to 2 vote.

The approval was also considered somewhat strange by some in light of the FDA's announced strategies to tackle the growing problem of opioid abuse. One such strategy is to introduce opioids with abuse-deterrent properties.

Last fall, the FDA announced stricter labeling on extended-release/long-acting opioids and plans to change the scheduling for hydrocodone combination medications, such as Vicodin (a combination of hydrocodone and acetaminophen) from Schedule III to Schedule II to increase security measures.

Since then, the approval of Zohydro ER sparked a call for its reversal by 29 state attorneys general and a coalition of groups calling itself "FedUp!: A Coalition to End the Opioid Epidemic." Bills have been introduced in both the House and the Senate to overturn approval of this drug.


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