FDA Restrictions, State Action, and Pharmaceutical Responses to the Abortion Pill

Caroline Tait

Associate Editor

Loyola University Chicago School of Law, JD 2024

Background

As of March 3, 2023, Walgreens, the second-largest pharmacy store in the United States, has announced that it will not offer mifepristone, the abortion pill, in twenty-one states. This decision followed letters written by Republican attorneys generals in the twenty-one states urging Walgreens not to stock the product, and even threatening legal action against Walgreens if they did decide to move forward with stocking mifepristone in those twenty-one states. Rite Aid and other pharmacies have not yet made a decision on whether they will sell mifepristone.

This Walgreens pharmacy change will specifically impact Kansas, Alaska, Iowa, and Montana, where mifepristone is currently legal, but susceptible to more restrictions. The change will completely ban the sale of mifepristone in Kansas, Florida, Georgia, Alaska, Indiana, Iowa, Ohio, South Carolina, and Utah, states which currently permit abortions.

This decision comes at an interesting time for mifepristone itself, as in early January, the FDA announced that it would “allow retail pharmacies to become certified to dispense mifepristone.” In response to this FDA announcement, Walgreens, CVS and other pharmacies announced their plans to stock mifepristone in states where abortion is legal. Following this announcement by pharmacies, the American Pharmacists Association warned pharmacies, like Walgreens and CVS, that they need to proceed with caution if stocking mifepristone in specific states as they may risk losing pharmacy licenses.

Last week, twelve states announced that they had commenced a lawsuit against the Food and Drug Administration (FDA), claiming that the FDA had issued too strict of restrictions on use of the abortion pill, mifepristone. The states suing the FDA over mifepristone are: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. These twelve states claim that the FDA’s restrictions on the drug are unsupported by evidence and that the restrictions include tight limits on which providers can prescribe and dispense the product.

Role of the FDA

The FDA issues guidance on use of mifepristone, Mifeprex (mifepristone) and its generic Mifepristone Tablets (mifepristone), stating as recently as January 24, 2023 that the drug had been approved “to end an intrauterine pregnancy through ten weeks gestation.” In 2000, Mifeprex was first approved by the FDA and in 2019 the generic version, Mifepristone Tablets, were approved. Although the FDA addressed the potential risks of Mifeprex and Mifepristone, known as the Mifepristone Risk Evaluation and Mitigation Strategy (REMS), the product was still approved as safe, with restrictions, and so long as it is not purchased online.

Responses to Walgreens decision

Representatives from liberal states such as Governor J.B. Pritzker of Illinois, responded to the decision by Walgreens by urging Walgreens to, “reconsider its decision not to sell abortion pills in some states during a meeting with the company’s seniors team.” Moreover, calls to boycott Walgreens following its decision not to stock mifepristone have spread online, putting the pharmacy at risk. As of the pharmacy chain’s announcement last week, the #BoycottWalgreens has trended on Twitter and spread across the Internet.

 Role of the states

States’ responses to mifepristone is interesting from a regulatory perspective as individual states’ decisions impact the rest of the country and individual businesses. Texas is one such state, as Texas is set to make a landmark decision concerning mifepristone and abortion regulations as of last week. U.S. District Judge Matthew Kacsmaryk is expected by many to “order the Food and Drug Administration to revoke its approval of the abortifacient mifepristone- effectively banning one of the two pills used in half of all abortions.” Judge Matthew Kacsmaryk’s involvement in this decision started in November when the case was filed by a conservative legal group seeking declaration that the FDA made an error in its 2000 approval of mifepristone and its generic counterparts.

The conservatives threatening both Walgreens and specific states are flaunting the regulatory authority of the FDA (or other decision-maker like individual states). Walgreens’ response to these threats is critical to its public reputation and integrity as one of the largest pharmacies in the country. How the other major pharmacy changes such as CVS, Rite Aid, Kroger, and Walmart respond to this decision by Walgreens will be critical. Also important is how aggressive progressive law makers will be as they continue to condemn Walgreens, the FDA, and Texas lawmakers. Additionally, the response of Walgreens in the coming days will be critical to its public reputation and integrity as a business.