Massachusetts cannot ban FDA-approved painkiller, judge rules

A federal judge on Tuesday blocked an effort by Massachusetts Gov. Deval L. Patrick to ban sales of a controversial new painkiller in the state, saying the governor’s move was preempted by federal law and could harm people who need the drug for pain relief.

In a five-page order, U.S. District Judge Rya W. Zobel sided with the drug’s California-based manufacturer, Zogenix, which had argued that Patrick had no right to bar a medication that the Food and Drug Administration has deemed safe and effective.

Zobel wrote that if the emergency order Patrick issued late last month banning Zohydro ER were allowed to stand, it “would undermine the FDA’s ability to make drugs available to promote and protect the public health.” She added, “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.”

In a statement Tuesday afternoon, Patrick (D) criticized the ruling as placing commercial interests above public health.

“Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper proof,” he said. “We will turn our attention now to other means to address this public health crisis.”

Part of a powerful class of painkillers known as opioids, Zohydro is the first drug composed of a pure dose of hydrocodone, the main ingredient in Vicodin. Previous hydrocodone drugs are available only in formulations that include non-addictive medications such as acetaminophen.

Proponents of Zohydro say the pure-hydrocodone form makes it possible for chronic pain sufferers to take the drug for long stretches without the risk of liver damage. The FDA agreed when it approved Zohydro last fall despite the objections of an outside advisory panel, which had voted 11 to 2 to recommend rejecting the drug.

The agency has faced a public backlash ever since from critics who argue that the pure formulation makes the drug easier to abuse, especially because the pill does not yet come in a tamper-resistant version.

Lawmakers from both parties have urged regulators to reconsider Zohydro’s approval. State attorneys general have warned that the drug could undermine efforts to fight the nation’s persistent prescription-drug crisis. Vermont Gov. Peter Shumlin (D) recently issued his own directive meant to make it more difficult to prescribe the drug.

Patrick has said that similar concerns about the drug fueled his decision to try to ban it in Massachusetts, where officials are grappling with what they say is an alarming increase in deaths related to prescription drug abuse.

Roger L. Hawley, chief executive of Zogenix, which sued the state to get the ban on its drug overturned, said in a statement Tuesday that the judge’s ruling “was a positive step forward for Massachusetts patients.” He added, “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.”

Brady Dennis is a national reporter for The Washington Post, focusing on food and drug issues.
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