Fairweather Federalism and Preemption

[Note from Matt: Meet Logan. He's our barely paid intern that attends some obscure law school in Cambridge, Massachusetts. He claims to be interested in psychedelic law. Before law school, he spent time working in Big Pharma. I think he’s a spy. Anyway, welcome to the team!]

As we often point out here, the American drug regulation system is built on a patchwork of authorities with overlapping jurisdiction and control. For example, as Matt recently pointed out, rescheduling a controlled substance goes through an archaic process where a recommendation (or, in that case, press release) is passed like a hot potato from one segment of the executive branch to another until it smolders for a while on DEA’s desk.

In other instances, federalism—a system of government in which two levels of government share jurisdiction—creates tension between the federal and state governments. Generally, the federal government regulates the introduction of drug products into interstate marketing while states govern the practice of medicine. But the line between the two isn’t always clear.

That invites the question: Is prescribing a drug “practicing medicine?”

My home state of Massachusetts says yes. Under 243 CMR 2.00, the definition of “The Practice of Medicine” includes “the prescribing . . . of drugs for the relief of diseases.” That invites a second question: Under a state’s authority to regulate the practice of medicine, can Massachusetts prevent a doctor from prescribing a certain medication — or does that encroach on the feds’ authority to regulate drugs?

For many of us, the answer depends on the drug.

When FDA approves abortion medication, pro-choice activists take the side of the feds and argue, based on preemption, that states cannot ban the drugs. But when DEA says cannabis (or psilocybin, or MDMA, or …) is a dangerous drug with no accepted medical use, pro-drug-choice advocates often hope the federal government will turn a blind eye as states roll out medical (and recreational) programs. Is there an inconsistency here? Let’s unpack those two (conflicting?) ideas.

Mifepristone

A recent 5^th Circuit opinion ruled that FDA overstepped its authority when it removed a handful of restrictions on mifepristone — a pill that induces abortion. The decision partially upheld a preliminary injunction issued by a Texas district court judge and would reinstate previous restrictions on the drug, including one that prevents patients from receiving mifepristone via the mail. Although the injunction is stayed pending a Supreme Court ruling on the issue, the case provides a starting point for our federalism analysis.

Why did the plaintiff, the Alliance for Hippocratic Medicine, bring the case in the first place? I can think of three theories:

1.     The organization is truly concerned with potential safety issues posed by rolling back FDA restrictions on mifepristone. (And with the doctors that must uphold their Hippocratic oath and treat women experiencing complications after taking mifepristone);

2.     Pro-life activists are not content with the “states’ rights” argument that results in abortion bans in only some of the states, and think that fully nullifying FDA’s approval of mifepristone would result in a de facto nationwide ban on mifepristone, bypassing those pesky legislators at the state and national levels; or

3.     FDA approval of mifepristone potentially bars any state from banning mifepristone — regardless of what it’s electorate or legislators think about abortion — under the doctrine of preemption.

The first two possibilities are self-explanatory, but let’s dig into the third.

Preemption is a judicial principle that stems from the Constitution’s Supremacy Clause, the part of Article VI that says that federal law is the “supreme Law of the Land.” Because federalism sets up a dual-sovereignty government, sometimes state and federal law clash, leaving the courts to determine the contours of state and federal power. Enter preemption—guidelines for how a judge should resolve the tension.

Occasionally, federal legislation will contain language that expressly preempts state law, which makes for an easy case. Other times, preemption is “implied” via two sub-categories—field preemption and conflict preemption. Field preemption occurs when Congress intends to “occupy an entire field”—when federal legislation is so comprehensive that it leaves no room for additional state laws. Conflict preemption, on the other hand, occurs when state laws make it impossible to follow federal laws (impossibility preemption) or if a state law frustrates the purpose of federal law (obstacle preemption).

In the past, federal courts have held that FDA approval preempts state drug bans. In 2013, FDA approved Zohydro, a powerful opioid, despite objections that the drug could be readily abused by crushing the pills and snorting or smoking the powder. Worried that Zohydro could exacerbate the state’s opioid crisis, Massachusetts outright banned Zohydro pending a modification to lower its abuse potential. Zogenix, Zohydro’s manufacturer, challenged the ban in federal court. The judge granted a preliminary injunction, finding that the ban “would undermine the FDA’s ability to make drugs available to promote and protect the public health”—an example of obstacle preemption. Massachusetts responded by imposing certain restrictions on practitioners that prescribe the drug under the state’s authority to regulate the practice of medicine.

Under that precedent, a state is unable to outright ban mifepristone, but perhaps could apply increased restrictions on prescriptions. Following the Dobbs opinion that overturned Roe v. Wade, Attorney General Merrick Garland invoked this exact argument, issuing a statement that “FDA has approved the use of the medication Mifepristone. States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”[1]

Now To Other (Fun) Drugs

How does the case of mifepristone — an important drug, but one without psychoactive properties as far as we can tell — fit into the topic of this newsletter? For starters, On Drugs is about all drugs, not just psychedelic or controlled ones. More important, the same federalist tension in the mifepristone debate undergirds drug law everywhere, including in psychedelic medicine.

Start with FDA approval. FDA approval of MDMA-assisted therapy appears to be a matter of when, not if. And yet, although psychedelic therapy has bipartisan support throughout the country,  one could imagine a state government (or its populace) worrying that their children will turn into glasses of orange juice and pushing back.[2] What happens then?

MDMA approval will automatically trigger federal rescheduling under the Controlled Substances Act (“CSA”). But the federal government is not the only player—states have their own versions of the CSA too. Around half of the state CSAs contain provisions that trigger state-level rescheduling upon federal movement. But what happens in the other states where there isn’t automatic rescheduling following federal rescheduling? It depends on the view you take on the federalism question. If there is preemption (like Zohydro) or if there isn’t (like mifepristone). I suppose someone could go to the courts to find out. 

For yet another wrinkle in the regulatory landscape, consider the many states that run programs for drugs that are expressly illegal under federal law. Cannabis is the obvious example. The federal government expressly bans cannabis as a Schedule I substance (subject to all sorts of goofy exceptions). Meanwhile, states thumb their nose at federal law and operate billion-dollar cannabis industries. While DEA tells us that cannabis has “no accepted medical use,” 38 states run medical cannabis programs.

Here, we are presented with a different spin on the federalism problem: if the federal government regulates drugs, and the federal government says a drug is illegal, can a state develop its own regulatory framework to promote access to and regulate that drug?

In other words, how we feel about federalism and preemption depends on the drug.

Conclusion

Fans of wide, unfettered access to both mifepristone and cannabis must come to grips with their fair-weather federalism. Federalism, it seems, is a two-way street. To protect mifepristone, some point to federal preemption that overrides a state’s individual choice where it contradicts federal policy. To defend cannabis, however, many of those same people deny federal supremacy and pass decision-making authority to the states.

These issues aren’t going away, and they aren’t getting any easier. In fact, psychedelics promise to make things even more complicated. FDA is poised to approve MDMA, and psilocybin will likely follow. State governments are crafting their own regulatory frameworks for psychedelics, reminiscent of cannabis during the last two decades. Either of these events alone could lead to a head-on collision of state and federal law and a ten-car pileup.

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[1] At least one judge disagrees. Judge Robert Chambers of the Southern District of West Virginia recently denied the theory that state mifepristone restrictions are preempted by FDA approval. GenBioPro, a company that manufactures a generic version of mifepristone, filed suit against West Virginia officials, claiming that the state’s restrictions on mifepristone are preempted by FDA’s approval. Chambers dismissed most of GenBioPro’s claims on the grounds that “regulating abortion is a matter of health and safety upon which States may appropriately exercise their police power.”

[2] Theoretically, a manufacturer could file a declaratory judgment action to force states to accept FDA approval for psychedelic therapy and expedite the roll-out.