by Leslie P. Francis
That’s correct: unless your prescription for misoprostol meets strict new conditions, possession of the drug is now illegal in Louisiana. In late May 2024, Louisiana governor Jeff Landry signed a bill making misoprostol and mifepristone schedule IV drugs, the most highly regulated controlled substances. Violating the law may result in jail sentences or fines.
These Louisiana laws, and laws in other states making medication abortion illegal or restricting access to the method, were not addressed by the Supreme Court’s rejection in June of the Alliance for Hippocratic Medicine’s challenge to the FDA’s approval of medication abortion. That case was brought by associations of physicians and physicians themselves who oppose abortion. The Court concluded that neither group had a significant concrete interest affected by the FDA’s approval to warrant standing. On the merits, it is a non-decision about this specific challenge to the FDA approval; the approval remains in effect. The state attorneys general of Missouri and Kansas have vowed to continue the challenge, although they too will face objections based on standing.
Other legal restrictions on abortion also are not affected by the Court’s decision. These include the federal Comstock law, a statute dating from 1873 that prohibits mailing drugs that can be used to produce abortion, state laws prohibiting medication abortion specifically, state laws prohibiting abortions, and now the Louisiana statute making medications used in abortion controlled substances.
Why did the Louisiana legislature act in this way? Louisiana already prohibits nearly all abortions except when necessary to protect the woman’s life or serious, permanent impairment of a life-sustaining organ of a pregnant woman. Louisiana also criminalizes knowingly causing an abortion by means of delivering, dispensing, distributing, or providing a woman with abortion-inducing drugs. A March 2024 report indicates that the result of these laws has been significant harm to pregnant patients in the state. The trouble for the state, however, has been that the presence of this statute on the books did not fully prevent abortions, given the continued availability of abortion pills into the state, shipped in the mail or brought by courier. Now that 63% of abortions in the US are achieved by medication, these Louisiana laws have been difficult to enforce in practice. And so, the state sought to deter people from bringing pills in or stockpiling pills to have them available for a later pregnancy.
Here’s what the law provides. Any drug containing any amount of either mifepristone or misoprostol is a Schedule IV controlled substance unless the drug is listed in another schedule. Possessing the drug is illegal unless it was obtained directly from or pursuant to a valid prescription from a practitioner. A prescription may be valid if it is for a bona fide medical reason other than an abortion—for example, to treat an ulcer. However, for a prescription of mifepristone or misoprostol to come under this exception for a bona fide medical reason, a diagnosis or diagnostic code must be written on the prescription indicating that the drug is intended for a purpose other than an abortion. The law also requires that authorized providers have a Louisiana controlled substances license and are automatically registered in the prescription monitoring program. In addition, prescriptions are not valid after six months and may only be renewed five times. Review of the information in the prescription drug monitoring program is required before prescription of any opioid; this provision would appear not to apply to mifepristone or misoprostol as they are not opioids.
This Louisiana law, along with other restrictions on medication abortion, will surely be challenged. One basis for the challenge will be federal preemption: can Louisiana impose these conditions on an FDA-approved medication, or does the FDA approval carry the day? Massachusetts tried not too long ago to impose state limits on a long-acting opioid that lacked sufficient safeguards, in the judgment of the state. The maker of the drug sued and the state lost several battles over preemption. Ultimately the parties agreed to dismiss the case so it did not result in a definitive ruling.
States can be expected to make many different arguments to avoid preemption. They might argue that state laws govern the practice of medicine, and that in limiting the conditions of prescription a state is regulating how professionals practice rather than the drug approval itself. States may also argue that licensing health care professionals is within the purview of the states. They may argue that criminal law is constitutionally reserved to the states. The commerce clause in both its active and dormant aspects will surely also come into play. So will the extent to which states can reach out extraterritorially to address what health care providers do in other states. In short, we are a long way away from being assured that access to mifepristone and misoprostol will remain comparatively open, whether these drugs are used for abortions or for other conditions such as ulcers.
In ruling as it did in Dobbs, the Court seems to have thought that returning abortion to the states would be a relatively simple matter. Instead, it is opening deep questions about the structure of US federalism. We explore many of these questions in our States of Health: the ethics and significance of policy variation in a federal system, published in May by Oxford University Press.
Leslie P. Francis, Ph.D., J.D., is distinguished Alfred C. Emery professor of law, distinguished professor of philosophy, and director of the Center for Law & Biomedical Sciences at the University of Utah.