, Newburyport, MA


April 24, 2014

Patrick's drug policy has the wrong focus

A federal judge last week struck a blow in favor of patients who suffer from debilitating pain and against the overreaching regulatory instincts of Massachusetts Gov. Deval Patrick.

U.S. District Court Judge Rya Zobel issued a temporary injunction halting the Patrick administration’s ban on sales of the painkiller Zohydro, an opiate produced by Zogenix Inc. and approved for use by the federal Food and Drug Administration. Patrick, citing a rise in heroin and opioid addiction in the state, banned Zohydro sales in Massachusetts last month.

Judge Zobel ruled that Zogenix was likely to prevail in a final ruling in the case and that the Patrick administration was wrongly interfering in a matter of federal authority. The Massachusetts ban on Zohydro is believed to be the first attempt by a state to prohibit sales of an FDA-approved drug.

“The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs here, opioid analgesics,” Zobel wrote, as reported by the State House News Service. “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.”

“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,” company officials stated in a release.

It is public health — and the Patrick administration’s skewed notion of that principle — that are of the utmost importance here.

Zohydro is a pure form of the painkiller hydrocodone. Unlike other formulations on the market, it is not mixed with acetaminophen, which can cause severe liver damage in higher doses. Zohydro is intended for patients suffering from pain so severe they require around-the-clock doses of the painkiller. Such intensive treatment with a painkiller mixed with acetaminophen could cause liver failure, putting the patient’s life at risk.

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