|April 21, 2014|
Previously published on April 16, 2014
When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce Clause and the federal Contracts Clause), we thought Zogenix would have a pretty good shot at a quick win on preemption grounds. But we were concerned about the implications a win for the Commonwealth could have on FDA’s stamp of approval - would it undermine FDA and the drug approval process?
As it turns out, after some briefing by the parties, the U.S. District Court for the District of Massachusetts does not think Governor Patrick has much of a case. Earlier this week, the court allowed Zogenix’s motion for preliminary injunctive relief and enjoined, until April 22, 2014, the Commonwealth from taking any action to implement or enforce Governor Patrick’s March 27, 2014 Declaration of Emergency and the March 27th order of the Commissioner of the Department of Public Health banning the sale and distribution of ZOHYDRO ER.
The court nicely teed up the preemption issue and swung through to a conclusion that the U.S. Constitution does not allow the Commonwealth to second guess FDA drug approval decisions:
The FDA endorsed Zohydro ER’s safety and effectiveness when it approved the drug. When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of DPH’s emergency order, did it obstruct the FDA’s Congressionally-given charge?
I conclude that it did. The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health. See Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000). The Commonwealth’s emergency order thus stands in the way of “the accomplishment and execution of” an important federal objective. Hines, 312 U.S. at 67. The Constitution does not allow it to do so.
Governor Patrick relied on the U.S. Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), to support the Commonwealth’s position that the Court not only rejected so-called “obstacle preemption” with respect to the FDC Act, but that consistent with Wyeth, federal regulation (here, FDA drug approval) is a floor and not a ceiling. That is, according to the Commonwealth, states can regulate over and above FDA. But the district court rejected the Commonwealth's reliance on Wyeth for both points. After noting that “obstacle preemption” is alive and well with respect to the FDC Act and that “Wyeth simply concluded that Congress did not view state tort suits as an obstacle to achieving the FDA’s purposes,” the district court continued with respect to the Commonwealth's second use of Wyeth:
Wyeth is a drug labeling case, and defendants present no evidence or persuasive argument that its reasoning should control in this different context. Furthermore, Wyeth assumed the availability of the drug at issue and analyzed whether stronger state labeling requirements obstructed the FDA’s objectives. Here, the obstruction is clearer because the drug Massachusetts wants Zogenix to adopt—Zohydro ER with an “abuse-resistant formulation”—has not been approved by the FDA. To 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.
Thus far things are looking well for Zogenix. And they are likely to stay that way . . . at least in Massachusetts. Whether or not the recent ruling in Massachusetts will now prompt federal lawmakers to push forward on legislation to withdraw the approval of ZOHYDRO ER (i.e., S. 2134 and H.R. 4241) remains to be seen. There has not been much action on either bill since they were introduced on March 13, 2014.