A US federal appeals court has ruled that access to a commonly utilized abortion medication, mifepristone will be limited due to the federal government’s failure to adhere to the correct procedures when it relaxed regulations in 2016, aiming to increase the pill’s accessibility.
The ruling, which would disallow mailing the pill or telemedicine prescriptions, marks the most recent advancement in a closely monitored legal case striving to eliminate abortion pills by challenging the FDA’s longstanding approval of mifepristone for 23 years. However, the current verdict will not have practical implications at the moment as the Supreme Court decided in April that mifepristone must remain accessible under existing regulations until the appeals process is finalized.
The Justice Department said it will go back to the Supreme Court to appeal Wednesday’s decision, which only partially upheld a lower-court judge’s ruling in favor of a coalition of antiabortion challengers.
Should the Supreme Court uphold the appeals court’s decision, accessing the abortion pill in the United States would remain possible, albeit with increased challenges for patients. It could also deny review, leaving in place the appeals court’s ruling, curbing but not eliminating access to the pill.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote in Wednesday’s opinion. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”
The justices will be navigating against the backdrop of their decision last year overturning Roe v. Wade, a ruling that led to a sharp drop in the court’s approval ratings, questions about its legitimacy and a political windfall for Democrats.
In that 6-to-3 decision, the conservative majority made a kind of promise, saying that the court was ceding the question of the availability of abortion “to the people and their elected representatives.” That could indicate a reluctance of hear a new abortion case.
Mifepristone, initially authorized for usage in the United States over two decades ago, constitutes one component of a two-drug combination utilized in over half of all abortions in the country. The legal dispute surrounding this medication has grown more intense following the Supreme Court’s reversal of Roe v. Wade’s constitutional abortion right in June 2022. This decision has led several states to impose additional restrictions or prohibitions on the procedure.
The Alliance for Hippocratic Medicine, comprised of antiabortion medical professionals and supporters, initiated the legal action against mifepristone. They argued that the FDA did not adequately address safety apprehensions during the drug’s initial approval in 2000 or when certain limitations were eased in subsequent years. For instance, the FDA extended the use of mifepristone up to 10 weeks of pregnancy instead of the initial restriction at seven weeks.
The challengers had argued that the abortion pill should never have been approved and should be removed entirely from the market. They filed their lawsuit in Amarillo, Tex., where U.S. District Judge Matthew Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge.
Kacsmaryk sided with the challengers and issued an unprecedented ruling in April, for the first time suspending FDA approval of a human drug over objections from the agency. His ruling embraced language used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”
It was promptly suspended to allow for an appeal by both the federal government and the pharmaceutical manufacturer.
“How mifepristone is used”
What is mifepristone?
Mifepristone is one of two drugs that work together to terminate a pregnancy, and is approved by the U.S. Food and Drug Administration through 10 weeks gestation. Mifepristone was first approved for use in France in 1988, and approved in the U.S. in 2000.
How a medication abortion works
Initially, a patient ingests a single pill of mifepristone, which hinders the hormone progesterone, thereby halting the advancement of pregnancy. Roughly 24 hours later, the patient usually consumes four pills of misoprostol. These pills induce contractions, leading to the expulsion of the embryo or fetus from the uterus.
Safety
A large body of research shows mifepristone is safe and effective. The American College of Obstetricians and Gynecologists analyzed hundreds of published studies, and found “serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3%.”
Mifepristone and abortion access
Mifepristone, utilized in over half of U.S. abortions as reported by the Guttmacher Institute, an organization advocating abortion rights, plays a significant role. If mifepristone becomes unavailable, abortion clinics would need to offer either surgical abortions exclusively or adopt a medication abortion approach involving only misoprostol.
Misoprostol-only medication abortion
In a misoprostol-only abortion, the process involves taking a total of three doses, each containing four pills. While misoprostol is commonly employed independently for abortion procedures globally, research indicates that it is not as efficient as the two-step regimen. Additionally, this approach often results in increased cramping and potential side effects such as diarrhea, fever, and chills.