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From Health Law Daily, July 10, 2014

State reg frustrates FDA approval of abuse-prone opioid

By Melissa Skinner, JD

A regulation issued by Massachusetts health officials creates an obstacle and frustrates the purpose behind the approval of the opioid analgesic prescription drug, Zohydro®. As such, a Massachusetts district court enjoined the enforcement of the regulation, which required physicians to supply a letter of medical necessity (LMN) with the prescription for the drug providing confirmation that other pain management plans had failed. The court, however, rejected the challenges to another regulation that stated pharmacy technicians, pharmacy technician trainees and pharmacy interns may not handle Zohydro (Zogenix, Inc. v Patrick, July 8, 2014, Zobel, R).

Zohydro. Zohydro, the only opioid analgesic whose only active ingredient is hydrocodone, was approved by the FDA in October of 2013. Although Zohydro does not contain acetaminophen, which is known to cause liver damage, it “lacks an ‘abuse resistant formulation’ permitting individuals to crush the pills, inhale or inject them, and immediately experience the full effects.” If taken as directed, however, Zohydro is an extended release medication, which dispenses itself over a 12 hour period after being ingested.

Regulations. Due to the concerns that the availability of Zohydro would increase opioid abuse in Massachusetts, the Governor issued an emergency order that banned “the prescribing, ordering, dispensing, or administration of Zohydro.” However, the Massachusetts enjoined the enforcement of the complete ban on the product, finding that federal law preempted the order. Subsequently, Massachusetts issued an additional emergency order which outlined several requirements that providers prescribing the product and pharmacies dispensing the product must follow.

Preliminary injunction. The manufacturers of Zohydro, Zogenix, Inc. (Zogenix), brought suit against certain Massachusetts health officials challenging and seeking preliminary injunctions with respect to two aspects of the prescribing and dispensing regulations on the drug. In particular, Zogenix argued that both the requirement that providers certify that other pain management treatments have failed in the LMN and that only pharmacists may handle Zohydro are preempted by federal law. In other words, Zogenix asserted that Massachusetts officials, in enacting such limitations on Zohydro “are trying to make scarce or altogether unavailable a drug that the FDA, by approving it, has said should be available.” According to Zogenix’s argument, this constitutes obstacle preemption, “which occurs when ‘under the circumstances of [the] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”

With regard to the certifications within the LMN, the court noted that several aspects of the requirement were ambiguous. For instance, the court poses the following questions: (1) exactly what pain management treatments must fail before it is appropriate for a physician to prescribe Zohydro; and (2) how long ago must the other plans of treatment must have failed before a physician may appropriately prescribe Zohydro. Based on the interpretations of these ambiguities, the court found that this regulation could “severely frustrate Zohydro’s availability” and, therefore, the court enjoined this aspect of the state’s regulations.

The court, however, failed to grant Zogenix’s motion for a preliminary injunction as to the requirement that only pharmacists handle Zohydro. The court noted that “neither party direct[ed] the court to any pharmacy’s announcement that it will or will not carry Zohydro.” Because it was therefore unclear whether the regulation would pose an obstacle to the FDA’s intention, the court found that Zogenix did not properly meet its burden in showing how the pharmacist regulation would preempt federal law.

The case number is 14-11689-RWZ.

Attorneys: Kenneth J. Parsigian (Latham & Watkins LLP), and Steven P. Hollman (Hogan Lovells US LLP) for Zogenix, Inc. Amy Spector, Attorney General's Office, for Deval Patrick.

Companies: Zogenix, Inc.

MainStory: TopStory PreemptionNews PrescriptionDrugNews SafetyNews MassachusettsNews

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