Just how far can a state go in regulating prescription drugs? The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and the Supremacy Clause. But we all know that it is not that simple. We are reminded every day when we come to work that states regulate prescription drugs by allowing state-law tort lawsuits, although federal preemption is a mighty shield where it applies. We are also aware that states regulate the practice of medicine, as well as regulating the pharmacies that dispense prescription drugs on doctors’ orders.
So before we blithely tell our various state regulators to stand down and keep their hands off, let’s take a more nuanced view, including revisiting what is going on in Massachusetts over the narcotic pain medication Zohydro. As we have previously said, Zohydro ER is an extended release version of hydrocodone, but it is the only hydrocodone analgesic on the market whose sole active ingredient is hydrocodone. Others contain acetaminophen, and removing that component mitigates the risk of liver damage for which acetaminophen is well known.
After the FDA approved Zohydro in December 2013, the state of Massachusetts and others tried to prohibit its use because of concerns over abuse. In Massachusetts, the state issued an emergency order banning the prescription, ordering, dispensing, and administration of Zohydro—essentially a state-law order taking an FDA-approved drug off the market. On April 15, 2014, the District of Massachusetts enjoined the law as an obstacle to the purposes and objectives of Congress. In other words, it was a textbook example of implied conflict preemption, and the only solution was for the state requirement to give way, which is what the district court held in granting a preliminary injunction. Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696 (D. Mass. Apr. 15, 2014). Our post on that decision is here.
To be honest, since a federal “yes” trumps a state “no,” we thought that would be the end of this particular controversy, if not the larger battle over prescription opioids generally. But we were wrong. One week after the district court’s order, Massachusetts replaced its blanket prohibition with a set of regulations that purport to limit, but not entirely prohibit the prescription and use of Zohydro. See Zogenix, Inc. v. Patrick, 2014 U.S. Dist. LEXIS 92382, at **3-4 (D. Mass. July 8, 2014). For prescribers, the regulations required individual assessment of each patient, including discussing risks and benefits and entering into “agreements” regarding the use, storage, and disposal of the drug. Most significantly, the regulations required that each prescribing physician supply a “Letter of Medical Necessity” indicating compliance with the regulations and verifying “that other pain management treatments have failed.” Id. at *4 (emphasis in original).
For pharmacists, the regulations limited who could handle Zohydro and set a number of prerequisites for dispensing the drug, including storing it in a locked cabinet, dispensing it in child-proof containers, reviewing the “Letter of Medical Necessity,” providing warnings and counseling, and checking the patient’s history. Id.at *5. Considered all together, the state’s message was that, if it could not outright prohibit the prescription and use of Zohydro, it would instead make doctors and pharmacists jump through so many hoops before the product reached the hands of patients that it would be too much trouble to try.
So now what do we do? For the record, we still think that state regulations such as these are preempted by federal law, but we acknowledge that burdens like those imposed here – as opposed to all-out prohibitions – present a more difficult issue. It’s at least the same sort of problem raised by recent state attempts to regulate into oblivion the off-label use of certain drugs used to terminate pregnancies.
The manufacturer moved again for a preliminary injunction, arguing with substantial justification that the regulations were a de factoban on Zohydro. And even if they were not, federal law still preempted the regulations because the FDA approved Zohydro for a specific use and purpose: “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” Id. at *10. The state regulations set a different standard: Instead of other options being merely “inadequate,” the state law requires that “other pain management treatments have failed.” According to the manufacturer, the state’s new requirement was preempted because it undermined the FDA’s power to approve drugs for specific uses. Id.
We think the manufacturer has a point, and so did the district court in holding that there is no “health” exception to federal preemption:
Sure enough, the Commonwealth’s police powers permit it to regulate the administration of drugs by health professionals . . . But it may not exercise those powers in a way that is inconsistent with federal law. Preemption principles have no less heft because health is a matter of “special concern” to the states. . . . To say as [the Commonwealth does], that they are exercising their constitutional authority does not answer the question. I must do as Savage [v. Jones] instructs and assess whether the regulations prevent the accomplishment of the FDCA’s objective that safe and effective drugs be available to the public.
Id. at *11. As we said the last time we discussed this case, helpful preemption authority sometimes comes in unexpected places, and this quote is a good one that we will store away.
On the merits of the dispute, the drug manufacturer got only half of what it wanted. Federal law preempted the prescriber regulation because its mandate that physicians verify that “other pain treatments have failed” was too vague. Exactly what “other pain treatments” must have failed? Other opioids? And how long ago must “other pain treatments” have failed? Zohydro is a scheduled drug, subject to a thirty-day maximum prescription. Does a doctor have to try “other pain treatments” every time he or she refills the prescription, or every second or third time?
At bottom, the Massachusetts regulations could be interpreted (including by the state’s own expert) as making Zohydro a last-resort opioid, thus making it less available, or even “severely frustrat[ing] Zohydro’s availability.” Id. at **13-14. According to the district court, “That presents a constitutional problem.” Id. at *13. Physician regulations enjoined.
The district court, however, denied the injunction of the pharmacy regulations because the manufacturer had not proved that the regulation would affect pharmacies’ willingness to carry the drug. Perhaps most telling, the district court noted both that the Commonwealth could move to lift the injunction and that the manufacturer could renew its motion on the pharmacy regulations “upon a more detailed submission.” Id. at *16. So unlike last time, we are under no illusions that the final word has been said. Will Massachusetts amend its regulations? Will the manufacturer hire pharmacy experts make another run? The answers are probably yes on both counts, and the resulting order will again help us understand just how far states can go in regulating prescription drugs.