Abortion access is, once again, at the center of national debate after the recent Supreme Court decision in Dobbs v. Jackson Women’s Health. The Court’s decision in Dobbs overturned constitutional abortion protections that were defined by Roe v. Wade and its predecessors going back nearly fifty years. This Article provides an alternative route and framework that could be used to ensure widespread access to abortion in the United States, despite the complete overhaul of Supreme Court precedent in the abortion context.
The Food and Drug Administration (FDA), a federal agency, is the primary regulator of prescription drugs. States, however, do have a role in governing public health and medical practice. Given the similarities between these two fields, there is an unsurprising amount of overlap and, sometimes, conflict between state and federal regulations. One of the areas in which we see an overlap of state public health regulation and federal drug regulation is in the administration of abortion medication.
Medical abortion is a procedure that uses medication to end a pregnancy. The medications used for medical abortions are mifepristone and misoprostol, which are typically administered orally, and are safest and most effectively used during the first trimester of pregnancy. Mifepristone and misoprostol are to be taken together. The FDA-approved regimen is as follows: (1) on day one of treatment, a dose of mifepristone is taken orally; (2) twenty-four to forty-eight hours later, a dose of misoprostol is then taken buccally (held between the patient’s cheek and gum until absorbed into the cheek); and (3) about seven to fourteen days after the mifepristone dose, the patient follows up with a health care provider. The follow-up visit is conducted to make sure the abortion is complete.
Mifepristone and misoprostol are prescription drugs regulated at the federal level by the FDA. In 2019, the FDA approved mifepristone and established a Risk Evaluation and Mitigation Strategy (REMS) program for the drug. The mifepristone REMS program ensures the drug’s benefits outweigh its risks, places limits on who can prescribe it, requires patients to sign an agreement acknowledging the risks, and, until recently in light of the COVID-19 pandemic, required in-person visits for dispensing it. States have implemented their own regulation of mifepristone, entirely separate from (but in addition to) FDA regulation and oversight. As of 2022, twenty-nine states require physicians to prescribe the medication, two states prohibit use after a specific time, and nineteen states require in-person visits.
As this Article will discuss, states continue to enact these regulations and make safety and efficacy decisions regarding drugs. States generally have the power to protect the public health of their citizens, which is a state justification for attempting to regulate drugs. However, Congress assigned the FDA statutory authority over the regulation of drugs. Any state laws that directly or indirectly regulate drugs are attempting to regulate a field which Congress so pervasively created federal regulation for that it left no room for state regulation. This effectively preempts state regulation under the doctrine of field preemption. Additionally, any state laws that conflict with the FDA’s drug safety decisions and regulations create an impermissible obstacle to Congress’ objective of the federal oversight of drugs, rendering state regulation preempted under the doctrine of conflict preemption. Lastly, the FDA could expressly preempt any state drug regulation by declaring the intent to do so via federal regulations. Ultimately, FDA regulation over medical abortion medications—namely, mifepristone and misoprostol—preempts all state laws which might seek to limit access to these drugs, contradict federal oversight of them, or otherwise regulate them. This preemption ensures some level of access to abortion in the United States, regardless of present or future state laws regarding abortion.