By: Micah Iberosi-Parnell, Esq. As many Americans probably know already, 2021 was a landmark year in the political battle over abortion rights. The Supreme Court heard two cases last term: Dobbs v. Jackson Women’s Health Organization, debating a Mississippi law crafted specifically to challenge Roe v. Wade; and Whole Woman’s Health v. Jackson, challenging the highly-publicized Texas law that bans abortion after six weeks and incentivizes private citizens to report abortion health providers to state authorities. If the Supreme Court’s six-justice conservative majority sides with the state defendants in either case, as several justices hinted during oral arguments, it would drastically increase states’ ability to restrict abortion before 24 weeks – the current line established by Planned Parenthood v. Casey nearly 30 years ago. As these cases have dominated national headlines, a quieter debate is emerging at the intersection of abortion rights, state police powers, and telehealth about a mail-order prescription drug called mifepristone, which allows patients to terminate a pregnancy up to 70 weeks of gestation. On December 16, 2021, the Food and Drug Administration (FDA) issued guidance that it would permanently allow mifepristone to be prescribed virtually and sent to patients through the mail. Although the drug was approved in 2000, the FDA imposed strict limits on access – including special provider certification and in-person patient consultation requirements – until the COVID-19 pandemic forced patients and providers to move to telehealth appointments.
The FDA’s move to permanently lift its limitations on mifepristone prescriptions came in response to the growing number of state restrictions on surgical abortions. For context, Texas state health officials revealed this week that its law, the same one currently being reviewed by the Supreme Court, resulted in a 60 percent reduction in surgical abortions in the state within a month of it going into effect. After the FDA announced its decision last December, Texas and other states that passed restrictions on surgical abortions scrambled to limit the effect of the new rules. Some states have taken a hard line and imposed criminal restrictions that risk jail time for prescribing physicians. Most states, though, (19 to be specific) have simply enacted laws that effectively preserve the old FDA rules by requiring in-person patient visits before prescribing mifepristone. Now, some abortion access advocates and legal scholars are suggesting that the Biden Administration should go on the offensive and challenge the new state restrictions in federal court by arguing that the FDA’s new rules federally preempt them. According to the 19th, an online news site, legal experts on constitutional law and abortion rights have said: “There is some support for the idea that states cannot ban FDA-approved medication … This is a novel legal argument. Maybe it would mean states cannot ban the sale of medication abortion, which would mean states must allow abortion up to 10 weeks.”
It would be unprecedented for the FDA to do this. States would likely counter-argue that such an action would exceed the FDA’s authority, a similar argument to the challenges that successfully struck down OSHA’s Employer Vaccine Emergency Temporary Standard. Here, specifically, the FDA is explicitly authorized by Congress to approve and regulate the manufacturing and distribution of drugs and medical devices. It indirectly affects how providers prescribe medication by limiting drug approval to certain illnesses and conditions, but these restrictions are primarily enforced against drug manufacturers – not providers. This is a major reason why doctors commonly prescribe off-label use for certain drugs (in fact, one out of five drug prescriptions in the U.S. are off-label). Instead, rules and regulations telling doctors and other medical services providers how they can and can’t practice medicine are traditionally issued and enforced by medical boards on the state level. These distinct regulatory schemes for drug enforcement and medical practice evolved from separate historical movements. President Theodore Roosevelt created the FDA in the late 1910s to address unsanitary manufacturing practices and fraudulent marketing for drugs and food. Meanwhile, most state medical licensing boards evolved after the Civil War (but before the 1900s) as a result of doctors and the American Medical Association lobbying individual states in an effort to legitimize the profession and limit competition from amateur, self-taught practitioners. Ultimately, it is impossible to know how a federal court would weigh this history and its accompanying legal arguments in a lawsuit over mifepristone. Despite this, this issue is likely to only become more high profile in the coming years and impact the ability of self-funded groups to cover these services.