By Kate Greenwood
Cross-Posted at Health Reform Watch
As Kurt Karst reported at FDA Law Blog, here, drug maker Zogenix has filed a Motion for Temporary Restraining Order and Preliminary Injunction challenging Massachusetts’ decision to “prohibit the prescribing and dispensing” of the company’s extended-release hydrocodone capsule, Zohydro ER. At a hearing on Tuesday, Judge Rya Zobel told the parties that she is likely to decide in the company’s favor. While Zogenix argues that Massachusetts’ action is unconstitutional for a number of reasons, including that it violates the dormant Commerce Clause and the Contracts Clause, Karst predicts that Judge Zobel will grant Zogenix’ motion on preemption grounds.
Zogenix argues in its Memorandum that “[t]he emergency declaration issued by Governor Patrick, and related order by the Commissioner of the Department of Public Health (DPH), purported to ban Zohydro™ ER based on safety concerns that squarely conflict with – and are therefore preempted by – FDA’s determination that Zohydro ER® is safe and effective and may be marketed and sold in the United States.” Zogenix notes that the reason Massachusetts gave for banning Zohydro—that the drug lacks abuse-deterrence features—was expressly considered by the Food and Drug Administration during the course of the approval process. FDA concluded that Zohydro’s benefits, in particular the fact that it contains no acetaminophen, outweighed the risks posed by its lack of such features.
Zogenix acknowledges that the Supreme Court’s decision in Wyeth v. Levine stands for the proposition that when the FDA approves the contents of a drug’s label, the agency merely establishes “a ‘floor’ upon which state tort requirements may build.” But, the company argues, “this is not a labeling case; it is a case about the safety and efficacy vel non of a drug already found to be safe and effective.” If Massachusetts’ ban is upheld, Zogenix concludes, “Congress’s objectives to promote the public health through FDA drug approvals could be directly contravened by a potential flood of state policy disagreements.”
While Massachusetts has not yet filed papers in opposition to Zogenix motion, there are a number of strong counter arguments it could make. First, while Zogenix emphasizes that the FDA “expressly” considered Zohydro’s lack of abuse-deterrence features, this is not an express preemption case. The federal Food, Drug, and Cosmetic Act does not expressly preempt the Massachusetts ban. Similarly, Zogenix uses the word “conflict” in its Memorandum, but this is not a case in which it would be impossible for the company to comply with both federal and state law. As the United States noted in an amicus brief submitted in the Supreme Court’s most recent FDA preemption case, Mutual Pharmaceutical v. Bartlett,
the FDCA makes FDA approval a prerequisite for, inter alia, “introduc[ing] or deliver[ing] for introduction into interstate commerce” any “new drug.” … That text does not expressly require that an approved drug be made available in any particular State or that the manufacturer be guaranteed the ability to make it so.
Finally, Zogenix argues that it was Congress’ intent that the FDA promote the public health by approving drugs for sale. One could as easily argue that it was Congress’ intent that the FDA do so without supplanting states’ authority to regulate the practice of medicine and against a backstop of states’ longstanding power to act as necessary to avert a public health emergency. The ban on prescribing and dispensing Zohydro was just one of a number of actions Massachusetts is taking as part of Governor Deval Patrick’s declaration that the “growing opioid addiction epidemic” in the state constitutes a public health emergency.
While Massachusetts can make a strong case against preemption, its case would be even stronger were Zohydro not a newly-approved drug. In its amicus brief in Bartlett, the United States argues that a state law tort claim founded on an allegation that a drug had a “design defect” would not be preempted if it were based on “significant new evidence” that was not before the FDA when it approved the drug at issue. Even if Judge Zobel strikes down Massachusetts’ ban on Zohydro, then, there may be room for states to act with regard to other drugs under other circumstances.