|Massachusetts Governor Deval Patrick|
It looks like Massachusetts Governor Deval Patrick's ban on controversial superstrength painkiller Zohydro won't stand--at least for now. After last week expressing her opinion that Patrick was "out of line" with his move to block the FDA-approved opiate, U.S. District Judge Rya Zobel granted maker Zogenix's ($ZGNX) request for an injunction temporarily halting the ban.
As MassLive reports, Zobel's granting of the injunction will take effect on April 22; Zogenix is also "likely to prevail" in the final ruling on the case, she said, labeling the state's arguments "without merit." Massachusetts Secretary of Health and Human Services John Polanowicz told the website his office would review the finding.
Patrick has said he banned Zohydro because it's a pure opiate that lacks features to deter abuse--Massachusetts' heroin and opioid addiction epidemic has claimed at least 140 lives in the past several months, MassLive notes. But the judge said in her ruling that the move undermines "the FDA's ability to make drugs available to promote and protect the public health."
"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," Zogenix officials said in a release seen by MassLive.
The company first filed the lawsuit in early April, blasting Patrick for taking unilateral action against Zohydro without giving it a heads up. Patrick also failed to respond to Zogenix's request for a meeting to discuss Zohydro, the suit alleges. "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," company CEO Roger Hawley said in a statement.
If officials take him up on his invitation, Hawley could find more than a few of them knocking on his door. Patrick is just one of several state legislators to take issue with the powerful pain med, which nabbed FDA approval last fall. More than half of the states' attorneys general have urged the agency to rescind its green light, with Vermont recently passing an emergency order placing restrictions on how doctors prescribe it.
The FDA has stood firm on its position, however; the drug is an important option for patients with severe chronic pain, Commissioner Margaret Hamburg has said.
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