The United States Food and Drug Administration (FDA) reviewed the pregnancy-terminating drug Mifepristone for four years, even though the drug was approved in nearly a dozen countries, including France, the United Kingdom and Sweden. The FDA’s review included a study of 16,000 participants, and approval was granted in 2000 after three rounds of evaluation, all of which resulted in an “approvable” letter. 

Despite this and the 2.75 million women who have utilized Mifepristone for miscarriages or medication abortions in the last two decades, it only took one man—Matthew Kacsmaryk, a Trump-appointed district judge in Texas—to temporarily suspend the FDA’s approval. Kacsmaryk is the only federal judge in the Amarillo Division in Northern Texas, and 95 percent of lawsuits filed there go to him, resulting in many conservative groups strategically choosing to challenge the Biden Administration’s policies in his division. 

Even if we look beyond that, usurping the FDA’s authority in this manner is unprecedented. 

No court in the United States has ever invalidated the FDA’s approval of a drug, forget going so far as to request the removal of Mifepristone from the market, like the plaintiffs in Alliance for Hippocratic Medicine v. FDA attempted.

Since the original approval of Mifepristone, the FDA has continually updated regulations. In March 2016, the FDA allowed other advanced clinicians such as nurse practitioners to prescribe Mifepristone, thereby loosening precautions associated with the original FDA-approval, in which only physicians could prescribe it. In April 2021, the FDA allowed Mifepristone to be mailed from medical businesses and practitioners due to COVID-19. Finally, this January, pharmacies were approved to distribute the drug over-the-counter. 

Even though the 2022 Supreme Court case Dobbs v. Jackson’s World Health Organization made abortion rights an individual state’s prerogative, Kacsmaryk’s ruling restricted the distribution of Mifepristone even in states where abortion is legal. 

After his ruling, one which cited data from the anti-abortion Charlotte Lozier Institute as well as anonymous blog posts, the Biden Administration appealed. The Fifth Circuit granted an emergency hold on the case as the statute of limitations on the original FDA-approval had already passed. Although this technically kept Mifepristone on the market, the Fifth Circuit approved Karcsmaryk’s restrictions, effectively repealing access to the FDA’s updated 2016 standards. Instead of having Mifepristone delivered through the mail after a tele-health appointment, patients would have to arrange three in-person visits with a doctor to receive the pill. 

The Department of Justice and drug manufacturer Danco filed emergency requests to the Supreme Court, asking to block the restrictions that the Fifth Circuit had upheld. The same day, Justice Samuel Alito temporarily stayed the Fifth Circuit’s decision, until April 19. He later extended the stay to April 21 while the Supreme Court considered the case. 

In an emergency ruling, the Supreme Court ruled to allow Mifepristone to remain widely available, putting a stay on the Fifth Circuit’s decision until the actual merits of the case. Essentially, the Supreme Court temporarily overturned the Fifth Circuit’s decision, returning the case back to the Fifth Circuit for arguments on May 17. It’s likely that the losing side will appeal to the Supreme Court again. 

Notably, the ruling made by the Supreme Court in this case is referred to as a shadow docket, or the use of emergency decisions without hearing oral arguments and without releasing any written opinion or justification for the decision. While each Justice’s vote is disclosed in typical cases, in a shadow docket, they are often left unknown.

In a time where the Supreme Court frequently rules on issues of political importance, the lack of transparency and accountability with shadow dockets is incredibly concerning. As Justice Elena Kagan stated, “[Shadow-docket  decision-making] every day [is] becoming more unreasoned, inconsistent, and impossible to defend.”

These emergency rulings are exclusively used when the court believes that an applicant will suffer “irreparable harm” if the request of appeal is not granted. In this case, the Supreme Court believed that financial and health harms existed to manufacturers of Mifepristone and the people who use the drug, respectively.

Although this ruling provides some semblance of hope for the millions of women who need Mifepristone, this case is a challenge to the FDA’s authority to approve and regulate safe medications—a challenge that should unequivocally be rejected. If the decision is later upheld, anyone could essentially challenge any drug or vaccine they disapprove of by claiming it could harm some people. Many believe that it could also disincentivize pharmaceutical companies from investing in research for new treatments or therapies.

Science, medicine, and public health has become a political issue, one underscored by this case. It’s an attack on the few abortion rights this country has left, veiled under largely illegitimate concerns of ‘safety.’

The decision in this case will be crucial for not only abortion rights, but the FDA’s role and the practice of medicine in its entirety. We can only hope that, for once this term, the ruling is in favor of science.