On August 16, 2023, the U.S. Court of Appeals for the 5th Circuit issued a new ruling in the ongoing litigation over the approval of mifepristone, the first in a two-step regime approved for medication abortion care in the United States. This marks just the latest episode in an unprecedented attempt by far-right activists to use the judiciary to interfere in the independence and judgment of the U.S. Food and Drug Administration (FDA), threatening not only abortion access but also the stability of all drug safety determinations as well as the legitimacy of the judiciary overall.
The safety and importance of medication abortion
Mifepristone has a decades-long history of safe and effective use. Since first approved by the FDA more than 20 years ago, medication abortion has been used by more than 5 million women and makes up the majority of abortion care in America. A wealth of evidence demonstrates the method’s safety and effectiveness as one of the most examined medications in America.
The importance of mifepristone availability has only grown in post-Roe America. Medication abortion—which can safely be taken in the privacy of one’s own home through the use of telehealth—has been essential to maintaining access as wait times have dramatically increased at clinics in states where abortion is legal due to women being forced to travel to clinics out of state, stretching providers past capacity.
Here is what to know about the 5th Circuit’s latest decision.
Access to mifepristone remains unchanged for now
Despite the 5th Circuit’s ruling that aims to reinstate some restrictions on mifepristone—described in more detail below—access to mifepristone remains unchanged. That is because the 5th Circuit’s decision is subject to a prior order from the U.S. Supreme Court that temporarily “stays,” or pauses, any restrictions on mifepristone for the duration of this case, until either the Supreme Court issues its own opinion on mifepristone’s approval or otherwise allows the 5th Circuit opinion to take effect. Essentially, this means that mifepristone will remain available in states where abortion is legal as litigation continues to play out—an essential fact given the massive confusion and chilling effects that have arisen for patients seeking abortion over the past year.
Mifepristone will remain available in states where abortion is legal as litigation continues to play out.
As of publication of this column, 15 states have in effect near-total abortion bans during any point in pregnancy, and six states have implemented abortions bans with other limits as early as six weeks. As both legislative action and litigation continue in many states throughout the country, these rapidly shifting laws are causing confusion, regardless of abortion’s actual legal status in states. In fact, earlier this year, polling indicated that in states where abortion is protected, nearly half of women—44 percent—didn’t know whether mifepristone was legal in their state.
The 5th Circuit seeks to overrule expert judgement to erode access to abortion
If allowed to go into effect, the 5th Circuit’s decision would effectively roll back the regulatory clock—and the corresponding years of medical consensus reflected in the FDA’s decision-making process—in order to reinstate restrictions on mifepristone that would make it harder to access. The decision’s impact would include requiring unnecessary trips to a doctor’s office and, notably, removing the ability of patients to access medication abortion through telehealth and end their pregnancies in the privacy and comfort of their own homes.
Telehealth access to medication abortion has proven to be a critical access point to care. In the year since Dobbs v. Jackson Women’s Health Organization was decided, the use of telemedicine for medication abortion services has increased dramatically, with research showing that patients seeking medication abortion care through telehealth services are just as satisfied with the service they received, if not more so, as patients who visit clinics in person.
Notably, the people who would be most harmed by judicial interference in expert rulemaking of this sort—low-income people and communities of color—often already face significant barriers to care, leading to disparities in health and overall well-being. If allowed to take effect, this decision would magnify those harms and put these people at further risk.
The Supreme Court is expected to rule on the case
All eyes are now on the U.S. Department of Justice (DOJ) and the Supreme Court as they determine next steps. Currently, the DOJ has a maximum of 90 days to appeal the 5th Circuit’s decision to the Supreme Court; and it has already confirmed it plans to appeal the decision.
After the appeal is filed, the Supreme Court will then decide if it will review the case. The Supreme Court has full discretion in regard to when to schedule the hearing, though a ruling may be likely in the first half of 2024. At that point, the Supreme Court can assess the heart of the legal issues in this case, which will ultimately determine not just access to mifepristone but also the authority of the FDA to determine the safety and efficacy of all drugs.
The Supreme Court’s next actions will demonstrate how far some justices may be willing to go to assert ideology before the rule of law.
As further action is awaited, it is also critical to be mindful of the litigation’s importance for the legitimacy of the judiciary overall. With records that demonstrate personal opposition to abortion, the judges who have issued opinions on the case have demonstrated a stark willingness to bend judicial norms in order to let the case continue to fester within federal courts. The Supreme Court’s next actions will demonstrate how far some justices may be willing to go to assert ideology before the rule of law.