Zohydro Court Win: Deep Splash, But Few Ripples

Declaring that FDA product approval cannot be voided by Massachusetts, federal judge erases what could have been a strong challenge to agency authority; ruling is unlikely to change other state/federal dynamics, however.

The April 15 court ruling that Massachusetts cannot ban Zogenix Inc.’s opioid Zohydro ER (hydrocodone extended-release) is at once banal and profound.

The case is banal because it confirms what was conventional thinking until a few weeks ago – that states cannot selectively opt out of the federal drug oversight system. But the case is also profound because it shows just how much the terrain has shifted for FDA in that a state would undertake a sustained effort to undue its approval process.

After this case, Massachusetts and similarly inclined states will serve as a reminder to FDA that regardless of how well balanced or well explained the agency feels its opioid policy is, there are going to be a large number of people who actively disagree with it.

Other industry stakeholders have similar state-based albatrosses around their necks: Brand pharma firms worry about drug importation legislation, and ANDA sponsors chaff at carve-out and Medicaid legislation that discourages use of generics.

State Ban Is About More Than Labeling, Judge Finds

The order by Massachusetts District Judge Rya Zobel granted Zogenix’s motion for a preliminary injunction against the state’s prohibition on prescribing and dispensing of Zohydro ER. Zobel framed the issue as a question of “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.”

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,” Zobel continues.

Massachusetts had argued that it had the authority to ban the product in part because of the Supreme Court’s 2009 decision which found that FDA-approved labeling does not preempt personal injury suits under state law (Also see "Zohydro v. Massachusetts = Wyeth v. Levine? State Asserts Power To Seek Label Change" - Pink Sheet, 14 Apr, 2014.).

But Zobel said that the Wyeth case “simply concluded that Congress did not view state tort suits as an obstacle to achieving the FDA’s purposes. … Defendants also contend that here, as in Wyeth, federal regulation is a floor, not a ceiling; if states wish to regulate over and above federal regulations, they may do so. But 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.”

Zogenix’s main claim was that the Massachusetts order was preempted by federal law based on the Supremacy Clause, which Zobel endorsed. “In view of this ruling, I do not consider Zogenix’s other arguments that the order violates the Contracts Clause and the Dormant Commerce Clause of the U.S. Constitution,” the order notes.

Broader Implications May Be Limited

Despite the Constitutional overtones of the case, the broader implications of it may in fact be limited. The case essentially affirms the status quo in terms of federal and state powers. Because of the ways it’s turned out so far, the case doesn’t appear to have much to say about two of the big state-centered Rx issues that could be brewing in the coming years – compounding and biosimilars.

On compounding, states seem eager to have FDA take the lead on enforcement to the extent that it can (Also see "FDA Compounder Inspections: States Taking Early Leave" - Pink Sheet, 31 Mar, 2014.). And this ruling doesn’t give any ammunition to compounders who might want to challenge the agency’s powers.

For biosimilars, states seem to be moving at their own pace to create substitution laws even in the absence of approved – let alone interchangeable – products, and FDA does not appear to be having a significant influence (Also see "Biosimilar Substitution Could Rely On Electronic Medical Records" - Pink Sheet, 17 Feb, 2014.).

Of course, the Zohydro case is only at the preliminary injunction stage. Massachusetts might try to create some prescribing limits that are less product specific, and Zogenix might try to stop them; precedential rulings could follow.

For now though, FDA must be satisfied with outcome of the case, but agency officials should also remain concerned that their opioid policies have become so polarizing that many elected officials are working to revoke their decisions.