Bioethics Blogs

A Second Zohydro Update

Last week I posted about Judge Rya Zobel’s order enjoining the Massachusetts Zohydro ban. While writing that post, I was wondering how Massachusetts would respond to the injunction. Now we know the answer. The night before the injunction was to go into effect, Governor Deval Patrick announced that the state would not appeal Judge Zobel’s order, and, instead of an outright ban on the use of Zohydro, Massachusetts would impose certain restrictions on its use similar to what Vermont has done.

The restrictions that Massachusetts has imposed include requiring Zohydro prescribers to complete a risk assessment and pain management agreement with patients, and participate in Massachusetts’s Prescription Drug Monitoring Program, which collects dispensing information on controlled substances to detect misuse.  If Zogenix chooses to challenge these restrictions – and I’m guessing it won’t because it hasn’t yet sued Vermont over its similar restrictions – one legal question would be: Are these restrictions, like the outright ban, preempted by federal law?

I think the answer to that question is likely “no.”  At least, I don’t think these restrictions would be preempted for the same reasons that Judge Zobel concluded that the ban on Zohydro was preempted.  In reaching her conclusion about the ban, Judge Zobel considered both that Massachusetts made an independent assessment of Zohydro’s safety and effectiveness that replaced FDA’s assessment, and that Zogenix could not market Zohydro in Massachusetts without going back to FDA for approval of an entirely new drug product. The new Massachusetts restrictions do not present the same challenges to the federal regulatory scheme because they do not so directly replace a federal action, and Zogenix can now market Zohydro in Massachusetts without any additional interaction with FDA.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.