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From Health Law Daily, April 16, 2014

Court invalidates Massachusetts emergency ban on Zohydro™ ER

By Michelle L. Oxman, JD, LLM

On April 15, 2014, a federal court in Massachusetts enjoined the enforcement of the ban on sales of Zohydro™ ER announced by Governor Deval Patrick on March 27, 2014. The court ruled that the state’s action was preempted by the FDA’s approval of the drug. The resolution of the constitutional question, i.e., whether the state could ban sales of an FDA-approved drug, was so clear that it outweighed any doubts concerning the equities or the balance of harms between the public and Zogenix, Inc., manufacturer of Zohydro. The court stayed the effective date of its ruling for one week, however (Zogenix, Inc. v Patrick, April 15, 2014, Zobel, R).

The FDA’s actions. As we reported on April 7, 2014, the FDA approved Zohydro as a Class II controlled substance in October 2013. The drug is a single-entity opioid, meaning that it consists entirely of hydrocodone without any analgesics, such as acetaminophen, which are commonly included in prescription opiates. On the same date, the FDA denied a petition by the Center for Lawful Access and Abuse Deterrence (CLAAD) and other advocacy organizations to deny approval of new drug applications (NDA) and abbreviated new drug applications (ANDAs) for opioid products in solid oral dosage forms unless they are backed by predictive or determinative data concerning their potential to reduce abuse, except when there is a shortage of drugs or an unmet public health need.

The FDA found that the proposed restrictions were “not feasible or appropriate” because abuse deterrence technology is in the early stages of development, and little is known about its effectiveness. It noted that the reformulated version of Oxycontin was expected to deter abuse, but the actual deterrence value was not yet established. In addition, the most common method for abuse of opioids is oral ingestion, and abuse deterrence technology does not address that threat.

Official opposition to approval. The FDA’s approval was greeted with alarm by attorneys general, health professionals, and others concerned with drug addiction and the dangers of overdose. In December, 28 state Attorneys General signed a letter asking FDA Commissioner Margaret Hamburg to reconsider the approval. The same week that Governor Patrick attempted to ban sales of Zohydro, the Attorneys General of Florida, Georgia, Illinois, Indiana, Kentucky, and Maine sent a joint letter to HHS Secretary Kathleen Sebelius asking her to “exercise leadership” to keep the drug off the market until abuse-deterrent technologies have been incorporated. Legislation has been introduced in both the House of Representatives and the Senate to reverse the approval until an abuse-deterrent formulation has been approved.

Opponents of the approval note that the FDA’s Analgesic and Anesthetic Advisory Committee recommended against the approval of Zohydro by a vote of 11 to 2 because of its potential for abuse and addiction and the lack of any abuse deterrence factor. Zohydro is available in single doses from 10 to 50 mg, containing three to four times the dosage of hydrocodone in other products. The danger of abuse and overdose results from the extended release formulation because abusers may easily defeat the extended-release feature by removing the powder from the capsule and ingesting it all at once, either orally or though injection. This form of abuse causes the user to experience a “rush” comparable to heroin. The increase in heroin addiction has been accompanied by an increase in overdoses of opioids.

Effect of the court’s ruling. The preemption doctrine flows from the Supremacy Clause of the United States Constitution, which states that the laws enacted by Congress are the “supreme law of the land.” State laws that conflict with federal law or present an obstacle to its implementation are unenforceable. The Supreme Court has ruled in Wyeth v Levine that state product liability suits against a brand name drug maker for failure to provide adequate warnings of the risks of a drug did not present an obstacle to the implementation of federal law.

Massachusetts argued that the ban was permissible because Wyeth permitted the states to impose higher standards than the federal government. However, the court ruled that Wyeth did not support the state’s position because it involved a more stringent requirement for labeling of the drug; it was possible for a manufacturer to comply both with federal and state law. An outright ban on the sale of Zohydro presented a direct obstacle to the FDA’s decision to allow the drug to be marketed.

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 CaseDecisions PreemptionNews DrugNews ControlledNews DrugBiologicalNews PrescriptionDrugNews SafetyNews MassachusettsNews

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