On April 15, 2014, in Zogenix v Deval Patrick 1:14-cv-11698-RWZ, the U.S. District Court in Massachusetts ruled that the Commonwealth overstepped its power to regulate the practice of pharmacy and medicine by, effectively reversing the Food and Drug Administration's (FDA's) approval of the opioid analgesic Zohydro ER. Massachusetts is not alone in its concern over this compound. More than half the states' attorneys general have called for FDA to reverse its approval and both the House and Senate introduced bills calling for its withdrawal.
Real Problem, Wrong Solution:
On March 31, 2014, after the Governor declared a public health emergency "with respect to the number of opiate-related overdoses and amount of opiate addiction," the Massachusetts Commissioner of Public Health issued an Emergency Order stating:
The scope of the order also prohibited out of state patients from obtaining prescriptions in state even if the prescription was to be filled out of state.
The manufacturer, Zogenix, challenged the Emergency Order on three grounds. Of the three, only one really mattered—federal preemption of the approval of prescription drugs, i.e. could a state override FDA approval and set its own safety requirements for approval of a prescription drug. The other Constitutional attacks were based on the Contract Clause and the Commerce Clause, interesting perhaps for constitutional scholars but probably losing arguments if the preemption issue had been lost.
The issue the Court addressed was whether the Massachusetts Emergency Order obstructed "the FDA's Congressionally-given charge" to assess safety and efficacy when approving drugs, and whether the state could interpose its own conclusion supplanting that of the FDA. According to the Court, "[t]o satisfy the Commonwealth, Zogenix would be required to return to the FDA and seek approval of a drug different from the one the FDA has already deemed safe." The Court recognized Congress' creation of the FDA and the primacy of FDA's power to approve drugs after assessing safety and efficacy. The District Court granted a preliminary injunction enjoining the Commonwealth from enforcing the Emergency Order but stayed enforcement of the injunction for one week.
In approving Zohydro, FDA did far more than simply rubberstamp approval. Here the evidence showed that the compound was formulated to address a specific and significant health problem. The manufacturer demonstrated that all other opiates on the market contained acetaminophen which caused tens of thousands of hospitalizations and hundreds of deaths each year. While Zohydro would not address the underlying opioid misuse and abuse outcomes, it would help alleviate acetaminophen poisoning. In this regard, the Court noted: "[a]s to the equities, although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers. For the same reason, the injunction is in the public interest."
States have an interest in regulating conduct to reduce the carnage from misuse and abuse of controlled substances and can exercise that power by placing safeguards through the regulation of the practice of medicine and pharmacy. What states cannot do, and what Massachusetts' Emergency Order did in this instance, was to remove an FDA approved product from the market.
Had the Court ruled in favor of the Commonwealth permitting states to set their own safety requirements for approved drugs, there is no limit to the unintended litigation such a ruling would have engendered.
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