West Virginia can restrict the sale of the abortion pill, despite federal regulators’ approval of it as a safe and effective medication, a federal judge has ruled.
U.S. District Court Judge Robert C. Chambers determined Thursday that the near-total abortion ban signed by Republican Gov. Jim Justice in September 2022 takes precedence over approvals from the U.S. Food and Drug Administration.
The commerce clause does not stop states from restricting the use and sale of medicines within that state. For example, different states have passed various laws restricting the use of opioids.
There’s a legal standard they would have to follow to avoid commerce clause problems called “undue interference.” IANAL so cannot define it directly for you, but it’d be hard to argue outright banning isn’t undue interference. Whereas regulations may be permissable in some cases like you mentioned with opiates. But you won’t see a state that has a law outright banning sale of an opiate that’s approved for use by the fda for this reason.
It’s not as simple as you suggest.
First of all, the “undue burden” standard was used pre-Dobbs to throw out state laws forcing women to jump through hoops before getting an abortion. It no longer applies to abortion post-Dobbs.
The Commerce Clause does not have an “undue burden” standard at all. It does prevent inappropriate burden of interstate commerce, but inappropriate means unfairly burdening other states. It is an anti-protectionist measure.
So for example if WV banned the import of mifepristone while allowing mifepristone to be produced and sold by West Virginian companies, this would be considered an inappropriate burden to commerce because it discriminates against other states.
States can still outright ban the sale of products in the state. Even products that have nationwide distribution and easy availability in other states, like fireworks and slot machines.
More generally, states are mostly responsible for medical licensing and prescriptions within that state. They can certainly regulate FDA approved drugs (after all, cocaine is FDA approved for some medical uses but is also subject to extensive state laws).
Mifepristone is in legally uncharted waters, but you shouldn’t assume that the Commerce Clause will necessarily protect it in this case.
Yes the phrase undue burden is nowhere in the commerce clause itself but is often in rulings regarding it and is often used in a commerce clause context, separate from it’s use in roe v wade related case law. https://www.law.cornell.edu/constitution-conan/article-1/section-8/clause-3/facially-neutral-laws-and-dormant-commerce-clause
The fda ultimately derived it’s authority from and was able to be created by the federal government because of the commerce clause, so it is related to this. Congress granted power to an authority that decides what medicines are or are not available and has kept this uniform between all states. Sounds like at this point it may come down to a supremacy clause question and the original wording of the law that created the fda. If it weren’t for the commerce clause the fda couldn’t even really exist in its current form. The judge in the case acknowledged this but decided to override supremacy clause concerns on the basis that historically he felt states should be able to regulate anything concerning medicine or healthcare providers. It seems to me though this is an area that’s been a very defined federally controlled system for interstate commerce reasonings for nearly a century now, prior to now you don’t see states trying to outright ban certain medications, at least not successfully. Once a medication was approved by the fda for a use it was always available in the whole country for that use. If it was generally understood that it was just like fireworks or some other random product I would have expected a states to have banned drugs at least once before. There’s other examples of products like this where federal government retains control for interstate commerce reasons, like California required a specific federal law giving them an exception before they could have their own regulations for cars sold on the basis of emissions. You do see certain medical procedures being banned, like conversion therapy, or uses of medicines that don’t have an fda label, like puberty blockers being banned for helping transgender children. But I’m not aware of examples of a state disallowing an explicit fda approval. If you have examples though I’d be curious. Ultimately I don’t feel really qualified to go any further on this, but I did find this write up helpful for anyone interested in more, and much better informed and written up than anything I could do. https://academic.oup.com/jlb/article/10/1/lsad005/7078178?login=false
I can say though if this is allowed to stand, I would expect even worsening interference by state governments into your doctor’s office and what they are allowed to prescribe or treat you with. I’d also expect continuing worsening of medical access and continuing flight of doctors and other health care providers to states that actually allow the free practice of medicine and use of fda approved medications.
Congress also created the ATF to regulate firearms, but that hasn’t stopped states from banning weapons and magazines that are not banned by the ATF.
Also note that CAFE is a special case, because Congress specifically wrote a provision in the law that states were not allowed to set more stringent emission standards unless they obtained a waiver.
Anyway, states haven’t really had reason to ban certain medications before, because until now medications were relatively uncontroversial. There is only one example I’m aware of: Massachusetts tried to ban a new opiate in 2014. They were sued by the drug manufacturer, and the judge sided with Big Pharma to undo the ban.
Massachusetts did not appeal, so apparently all we have for now is two contradictory opinions by two lower courts. In other words, legally uncharted waters. While one can certainly hope that future rulings will undo the mifepristone ban, realistically most observers acknowledge that preemption is a complex issue and neither side is certain to prevail.
I’m not sure the atf is going to be the best analogy because of some specifics in the law creating the fda, explicitly disallowing states or other bodies to make their own judgements on prescription drugs. Thanks for the other example of a time this was attempted, let’s hope the ruling in the Massachusetts case wins out before the supreme court destroys the FDA and wreaks more havoc on the practice of medicine in the US.
Even THAT seems to be on shaky ground after National Pork Producers Council v. Ross. California’s 2018 Prop 12 arguably DOES create a protectionist statute and SCOTUS tied themselves into knots trying to reach a resolution.
In his solo opinion Justice Kavanaugh expressed concern over the rise of precisely this kind of thing. You can find it at the end of the 2nd link.
Has the FDA ever tried to challenge those though?