Since FDA approved Zohydro in October 2013, the drug has been the subject of quite a bit of controversy. In short, the concern is that Zohydro will contribute to the serious prescription drug abuse problem in the U.S. because, as an extended-release drug, it contains a higher dose of hydrocodone than other hydrocodone drugs on the market, and it lacks abuse-deterrent properties (see, e.g., this New York Times blog post). Perhaps the most interesting part of this controversy is that Massachusetts has attempted to ban the use of Zohydro in that state—which I think makes Massachusetts the first state to flat-out ban an FDA-approved drug.
As we discussed in our recently posted April podcast, Zogenix Inc., Zohydro’s sponsor, sued Massachusetts over this ban (here’s the complaint). When we recorded the podcast, the federal judge – Judge Rya Zobel of the District of Massachusetts – had not yet ruled on Zogenix’s motion for a preliminary injunction, and I predicted that she would not enjoin Massachusetts from enforcing the ban on preemption grounds. Well, I was wrong. On April 15th, Judge Zobel enjoined Massachusetts from enforcing or implementing its Zohydro ban because she concluded that Massachusetts “obstructed the FDA’s Congressionally-given charge” when it “interposed its own conclusion about [Zohydro’s] safety and effectiveness” (here’s the order).
To back up a bit, the Supremacy Clause of the Constitution provides that federal law is the “supreme Law of the Land . . . Laws of any State to the Contrary notwithstanding.” In other words, as Judge Zobel explained, “state law that conflicts with federal law is without effect.”
Under Massachusetts law, when the Governor declares a public health emergency, the Commissioner of the Massachusetts Department of Public Health may take action that she deems necessary to “assure the maintenance of public health and prevention of disease.” Pursuant to this law, Governor Deval Patrick declared a public health emergency in response to the “growing opioid addiction epidemic,” and directed the Massachusetts Public Health Commissioner to take a number of actions, including prohibiting the “prescribing and dispensing” of Zohydro until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.” Meaning that – according to Zogenix’s complaint — Zohydro must be re-formulated with abuse-deterrent properties before it could be used in Massachusetts.
Because prescribing and dispensing are traditionally thought of as part of the practice of medicine, which, in turn, is generally considered to be regulated by the states, I thought that the Massachusetts ban might be crafted cleverly enough to dodge the preemption bullet. In other words, I think there is an argument that the Massachusetts ban did not conflict with federal law, because the Massachusetts ban regulated medical practice, while federal law regulates the medical product. (Kate Greenwood, of Seton Hall Law, made a similar point in a Health Reform Watch blog post.)
But Judge Zobel did not see it that way, concluding that Zogenix is likely to prevail on the merits of its claim that the Massachusetts ban is preempted by federal law because “Congress required FDA to protect the public health by making sure that drugs are safe and effective,” and the Massachusetts ban conflicted with this Congressional intent by substituting Massachusetts’s determination about Zohydro’s safety and effectiveness for FDA’s.
Judge Zobel also distinguished this case from Wyeth v. Levine—the 2009 decision in which the Supreme Court held that state law failure-to-warn claims against innovator* drug companies are not preempted by federal drug labeling laws and regulations. In that case, a patient whose hand and forearm were amputated after an IV push of Phenergan caused gangrene, sued Phenergan’s sponsor, Wyeth, for failing to adequately warn about the risks of IV-push administration. The Court concluded that, although FDA had approved the label for Phenergan, the patient’s failure-to-warn claims were not preempted because Wyeth could have strengthened the warnings without FDA’s prior approval (through the submission of what is known as a changes-being-effected supplement), and, more relevant to the Zohydro litigation, allowing state law failure-to-warn claims did not interfere with the consumer protection purpose of the Federal Food, Drug, and Cosmetic Act. Judge Zobel concluded that the Massachusetts ban, on the other hand, obstructed the purpose of the Federal Food, Drug, and Cosmetic Act by replacing FDA’s assessment of a drug’s safety and effectiveness with a state’s assessment, undermining FDA’s ability to promote the public health through access to safe and effective drugs. Judge Zobel also noted that Zogenix could not comply with what Massachusetts was asking for – an abuse-deterrent formulation – without going back to FDA for approval of a different drug product.
I think Judge Zobel’s order was unquestionably the right decision from a public health perspective. Even if you think the Zohydro approval was a bad one (and I don’t necessarily think it was, for reasons I partially explain in our April podcast), there are other ways to make that case to FDA. More importantly, the Massachusetts ban would establish a problematic precedent. A patchwork of different requirements for drugs across the country, made by states that lack FDA’s scientific expertise, wouldn’t be good for patients or for encouraging the development of innovative new drugs. In addition, I also think Judge Zobel made a persuasive argument for this being the right decision from a legal perspective. Viewed broadly, the Massachusetts ban does undermine FDA’s role as our medical product gatekeeper, and there seems to be good reason to distinguish the Zohydro case from Wyeth v. Levine.
* Judge Zobel’s order did not address the other two major, recent Supreme Court decisions concerning drug labeling and preemption—Pliva v. Mensing and Mutual Pharmaceutical v. Bartlett. Those decisions, however, concerned generic rather than innovator drug labeling.