Thursday, April 24, 2014

Massachusetts Cannot Ban Hydrocodone-Only Medications, Federal Judge Rules

A US District Judge has ruled that Massachusetts may not ban the prescribing and dispensing of hydrocodone-only medication products that have been approved by FDA. Following months of controversy surrounding FDA’s decision to approve Zohydro™ ER, the first hydrocodone-only medication to be approved by FDA, Governor Deval Patrick declared the state’s opioid addiction epidemic to be a public health emergency. As part of the state’s response, Patrick ordered an immediate prohibition on prescribing and dispensing of all hydrocodone-only products. Zohydro ER manufacturer Zogenix, Inc, filed a three-count complaint alleging that the state’s ban on the medication was unconstitutional. Rya W. Zobel, US District Judge ruled (PDF) that the state’s emergency ban on the drug is preempted by federal law. Further, Zobel notes, “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.”

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