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  • Brody Faliero

Navigating Mifepristone Litigation: Supreme Court Challenges and Massachusetts' Stand

Courtesy of Matthieu Landretti

Amidst legal discourse concerning accessibility to the abortion medication mifepristone, Massachusetts stands out as a proactive advocate for reproductive healthcare rights. This discourse has been pronounced by a recent and ongoing Supreme Court case, FDA v. Alliance for Hippocratic Medicine, in which the FDA is being sued for harming people’s health and safety by making the drug more easily accessible. This article traces the historical development of mifepristone, explains how it has led to the current Supreme Court case regarding its accessibility, and explains what measures Massachusetts has taken to safeguard its access for residents. 

The central figures in mifepristone’s history are chairman Edouard Sakiz of Roussel Uclaf, a prominent French pharmaceutical company, and endocrinologist Etienne-Emile Baulieu. Baulieu began studying fertility control in the 1960s, initially focusing on hormone research. In 1970, he identified uterine cell receptors for progesterone, sparking the idea to develop a method to block this pregnancy hormone and revolutionize women’s reproductive healthcare. He shared the concept with Roussel Uclaf, where Sakiz eventually supported the project after overcoming pressure from the Catholic Church. In 1980, the company successfully developed mifepristone as an anti-progesterone medication. Following clinical trials revealed that the drug could also induce abortions when combined with prostaglandin medication, which helps produce uterine contractions. It was highly effective, and reshaped reproductive healthcare by offering an alternative to surgical abortion for people seeking to terminate pregnancies. 

Contraceptive innovation continued to advance in Europe while facing significant regulatory challenges in the U.S. due to political pressure and anti-abortion sentiments influencing the FDA’s approval process. The FDA banned the drug in 1989, inspiring prominent abortion rights activist Lawrence Lader to come up with a creative solution to making the drug accessible. Despite facing legal issues importing the drug, Lader managed to sneak a dose into the country. He set up a lab in Westchester County, N.Y., to manufacture it using published patents. Lader then provided it to researchers to conduct U.S. clinical trials in 1994 to prove its safety and efficacy. After years of contentious legal battles, the FDA approved mifepristone for medical abortion in 2000. The FDA also implemented regulations in 2016 and 2021, which significantly expanded access to abortion medication, including the allowance of telehealth and mail-in options for prescribing and obtaining the drug. Today, while an estimated five million American women use the medication, this expansion is being reconsidered.

The Supreme Court is currently deliberating on the accessibility of mifepristone due to concerns from the Biden administration and the drug manufacturer about a ruling by the U.S. Court of Appeals to walk back the FDA’s added avenues for obtaining the drug. The plaintiffs in the Supreme Court case are four anti-abortion medical organizations and four anti-abortion doctors, represented by a conservative Christian legal group called the Alliance Defending Freedom. They are suing the FDA for removing safety standards for pregnant individuals who use mifepristone and misoprostol, arguing that the FDA’s evaluation of the drugs’ safety risks, which informed their expansion of access, was inadequate. Overturning these regulations would mean only a specially certified doctor could prescribe the drug. The patient would also have to pick it up in person and visit the doctor three times during the abortion process. 

The court heard appeals from the Biden administration and the drug's manufacturer on March 26, challenging the federal appeals court ruling to limit access and the Alliance Defending Freedom’s arguments supporting it. The outcome of the case is unpredictable, but the hearing conversations seemed to lean skeptical that the doctors represented by the Alliance Defending Freedom can prove that they have a legal standing to challenge the FDA’s decisions. This procedural issue cannot be resolved unless the plaintiffs can show reasonable proof that the FDA’s expansion efforts have put them at direct risk of injury. They attempted to do so by arguing that they would be harmed by their forced complicity in the termination of a pregnancy as a result of treating a patient who experienced complications from a medication abortion. Justice Sonia Sotomayor notably responded to this argument by suggesting that there is an "infinitesimally small" chance that a pregnant woman who needs medical attention after taking mifepristone would end up seeking care from one of the represented physicians or organizations. Justices Brett Kavanaugh and Clarence Thomas, though, appeared to find the plaintiff’s arguments compelling. While the Court seemed to lean towards rejecting Alliance Defending Freedom’s challenges to the FDA’s decisions, the outcome of the case remains undetermined. 

The Supreme Court ruling has the potential to reverse the progress made toward accessible reproductive healthcare in all states. Massachusetts, however, has long-supported abortion rights and has taken measures to mitigate the potential impacts of such regressive rulings. On April 10, 2023, Governor Maura Healey (D-MA) announced measures to protect access to mifepristone following a federal court ruling in Texas blocking FDA approval of the drug. The Governor emphasized mifepristone's safety and legality, insisting that one judicial decision will not affect Massachusetts' commitment to safe care. She then ordered the state’s healthcare providers to stockpile doses of the drug, along with UMass Amherst, which procured 15,000 doses with the help of the Healey-Driscoll Administration, allocating $1 million to the efforts. At that time, Governor Healey also saw that an Executive Order was instituted to protect abortion medication under state law, specifying medication abortion providers are protected from legal repercussions by the Shield Law. 

In Massachusetts, mifepristone currently remains accessible without restrictions. In light of this new attack on abortion medication access, Governor Healey restated her commitment to protecting medication abortion access, applauding CVS and Walgreens for their decision to dispense mifepristone in several states, including Massachusetts, in early March. Planned Parenthood also provides Massachusetts residents access to mifepristone via telehealth appointments, along with various other healthcare providers in the Boston area. 

The resurgence of this debate regarding access to mifepristone in the face of decades of overwhelming evidence that the drug is safe and effective underscores the instability of this moment in the history of reproductive rights. The federal approval of mifepristone marked what was perhaps the most significant milestone in U.S. reproductive healthcare since Roe v. Wade. The Alliance Defending Freedom is, notably, the same group that successfully advocated for the Supreme Court's decision to overturn Roe v. Wade, further highlighting the gravity of this current case’s implications on women's autonomy over their bodies.

If successful, the restrictive measures sought by the plaintiffs would not only undermine the FDA's efforts to improve access to safe reproductive healthcare but also contribute to the unraveling of decades of hard-won progress in safeguarding reproductive rights. In Massachusetts, Governor Healey's proactive response to this threat exemplifies the reaction of a government committed to protecting and fighting for women’s safety. 


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