On January 3, 2023, the U.S. Food and Drug Administration (FDA) updated its risk evaluation and mitigation strategy (REMS) for reproductive health relating to “the abortion pill,” mifepristone. Mifepristone is a pill, used in combination with misoprostol, to terminate intrauterine pregnancies no later than 10 weeks past the individual’s last menstrual period. Additionally, it may be used for early-stage miscarriage management, and management of 2nd and 3rd trimester pregnancies where the fetus is no longer viable and has died before birth.
In 2011, the FDA implemented the Mifepristone REMS Program to place restrictions on the drug’s distribution and use. Specifically, it implemented an in-person dispensing requirement where the drug may only be dispensed in a clinic, medical office, or hospital through direct supervision of a certified clinician. This prohibited mifepristone from being sold in retail pharmacies or through the mail. The drug’s restrictions were criticized for creating barriers to patient access for medicated early-stage abortions and management of pregnancy loss. Additionally, those that opposed the restrictions claimed its implementation disproportionately harmed minority groups and communities that faced structural barriers to reproductive care. This accelerated throughout the COVID-19 pandemic, and advocacy efforts spearheaded by the American College of Obstetricians and Gynecologists pushed the FDA to reform the REMS program.
In 2021, the FDA completed a review of the REMS Program and set to modify the restrictions to help improve patient access and create efficiencies in health care delivery. Implementations of the Program’s modifications were halted until the FDA approved mifepristone’s updated prescription information by their manufacturer, resulting in the implementations officially going into effect on January 3, 2023. The FDA’s update removed the in-person dispensing requirement and a new pharmacy certification process was added that allows certain retail pharmacies to dispense mifepristone directly to patients who have a prescription. Additionally, given the impact of the Dobbs decision, this update will affect clinic practices based on the abortion laws and regulations of the state that the practices reside in.
Following the FDA’s updated policy, stores like Walgreen and CVS planned to offer mifepristone through their pharmacies in the states that legally allow abortions. However, on March 3, 2023, Walgreens publicly stated it would not be dispensing mifepristone in 20 states after being threatened by public officials. Headed by Missouri Attorney General Andrew Bailey with other attorney generals from Republican run states, a warning letter was issued to CVS and Walgreens on February 1, 2023. The letter alleged abortion pills sold through the mail would be federally illegal based on the Comstock Act, claiming the Act includes language that prohibits the mailing of articles designed to prevent conception or induce an abortion.
In early January of 2023, the Department of Justice (DOJ) noted that the Comstock Act does not prohibit abortion pills being mailed when those sending the pills lack intent that the drugs will be used for illegal purposes; however, Bailey argued against the DOJ and claimed the text of the Act is what governs, not “the Biden administration’s view.” Bailey further threatened CVS and Walgreens with civil litigation through either state attorneys or private citizens.
Walgreen’s announcement affects states where medication for abortions is legal, such as Alaska, Iowa, Kansas, and Montana. In a statement, Walgreens specified that once it was certified by the FDA to sell the abortion pill, the company will dispense the drug complaint to state and federal laws. The threat to selling mifepristone has opened a larger question about state authority in regulating FDA approved drugs and medicated abortion access. Since Walgreen’s announcement, activists have pushed to boycott Walgreens. Currently, there are 2 lawsuits arguing that states do not have the authority to regulate FDA approved drugs; one targeting a state’s restriction on abortion pills, and the other challenging West Virginia’s state abortion ban. If the court rules in favor of the plaintiffs in these cases there may be grounds to claim that FDA policy trumps state law on abortions, but more time is needed to determine the outcome of bans on the abortion pill through state and federal action.