Using the FDA as a Political Football: The Lawsuit Against Abortion Medication Mifepristone

An array of reproductive health supplies including oral contraceptives, condoms, IUD, etc. Photo by the Reproductive Health Supplies Coalition.

The trusty argument of “states’ rights” makes a return in the case of abortion rights. In the tumultuous summer of 2022, the Supreme Court overturned Roe v. Wade and replaced its precedent with Dobbs v. Jackson. In the Dobbs’ opinion, the conservative majority held that states should set abortion rights themselves. Over the next few months, voters in states such as Kansas and Kentucky went to the ballot box to voice their disapproval on proposed amendments to state constitutions that would outlaw abortion. They were successful—in the 2022 election, six states where abortion rights appeared on the ballot failed to pass similar measures. However, a new lawsuit filed in Texas claims that the U.S. Food and Drug Administration's (FDA) approval of mifepristone, a medication typically used with another drug to induce an abortion, is illegal and should be overturned. The outcome of this ruling could change how states protect their abortion rights moving forward. The Texas ruling would not only change the abortion law landscape, but more consequentially, it would degrade the FDA into a political weapon used for health policy positions. 

Alliance Defending Freedom, a conservative group advocating for the outlaw of abortion, filed a lawsuit against the FDA’s approval of mifepristone in November 2022. As of 2022, medication abortions make up more than half of all abortions in the U.S. Medication abortions increase access to abortions because healthcare professionals can prescribe the medication through telehealth visits, and patients can undergo treatment at home instead of having a surgical abortion. Mifepristone is half of the two-prescription treatment commonly prescribed to terminate a pregnancy. It is a tablet that, taken in conjunction with misoprostol, can terminate an intrauterine pregnancy up to ten weeks after a patient’s first day of their last menstrual cycle by blocking progesterone and causing uterine contractions. Patients can take misoprostol on its own, but using vaginal misoprostol has only a 60% efficiency rate. 

The medication was first approved in 2000, and a generic version was approved by the FDA in 2019, which expanded access to the medication. Women can still obtain an abortion in states that have outlawed them because patients can request a telehealth visit in another state. As a result, revoking mifepristone’s FDA approval will significantly decrease the number of terminated pregnancies and increase the burden on those women. Not only would it eliminate medication abortions in abortion-restricted states, but it would also revoke the right to medication abortion in states where abortion remains legal. Alliance Defending Freedom stated that the FDA’s approval of mifepristone is unlawful and puts women and girls at risk. The group’s actions were intentional, and they strategically chose to file their case in Amarillo, Texas, a state already known for its restrictive abortion laws. Furthermore, the case has been appointed to Matthew Kacsmaryk, a Trump-appointed judge with conservative views on abortion. Since the lawsuit’s filing, attorneys general from twenty-three Republican-led states have filed briefs in support of the Alliance Defending Freedom’s position. They argue that the FDA’s approval of mifepristone undermines states’ endeavors to restrict abortion by allowing patients a way to circumvent their states’ laws, and “thus harms the public interest.” Democratic attorneys general have fought back in their own brief declaring that the lawsuit actually infringes on their right to increase access to abortion in Democratically controlled states. 

If Judge Kacsmaryk rules that the FDA’s approval of mifepristone is unlawful, it would be an unprecedented move against the FDA and could cause the FDA to be thrust into the middle of political debates. Although the legislative and executive branches oversee the appointment of the FDA commissioner and determine the size of the agency’s budget, the FDA is largely removed from the partisanship of Washington. If Judge Kacsmaryk overrules the approval, parties will be empowered to influence the FDA into becoming a political tool. 

If the FDA does not stand its ground against the lawsuit, a precedent could be set which allows Republican and Democratic policymakers to sue the FDA to carry out their health policy agendas. For instance, whether or not vaccine requirements should exist have been a political hot button over the years. If the FDA is politicized, advocates against vaccine requirements could try to take the FDA to court to debate the safety of a vaccine as an avenue to bypass the vaccine requirement. Alliance Defending Freedom bases its lawsuits on its belief that mifepristone is harmful to women and girls and that the FDA approval puts them at risk. The FDA and abortion rights activists should publicly fight back against political agendas with scientific data that over the last two decades of mifepristone’s approval, only 0.4% of patients experienced serious complications. 

The FDA cannot be completely insulated from the politics of Washington. Still, the FDA’s review processes are primarily based on empirical data and should not adhere to political agendas at the expense of constituents’ health. If the court orders the FDA to overturn its approval of mifepristone, the bureaucracy will turn into a playground for Republican and Democratic lawmakers. Will this be the case? We certainly have seen precedent struck down before. 

UPDATE: On April 7, 2023, Judge Matthew Kacsmaryk issued a hold on the FDA’s approval of mifepristone. That same day, Judge Thomas O. Rice, an Obama appointee in Washington State, issued the opposite decision stating that authorities cannot restrict access to the drug. These conflicting decisions will most likely force the Supreme Court’s hand in making the final ruling.

Kristy Wang is a Staff Writer for the Columbia Political Review and a junior in Columbia College studying political science and biology. Kristy can be reached at kw2933@columbia.edu.