District Court Judge Matthew Kacsmaryk of Amarillo, Texas, imposed a nationwide injunction revoking the U.S. Food and Drug Administration's (FDA) approval of mifepristone. As a result, it will pull the abortion pill from shelves nationwide. Notably, this is not a nationwide ban on all forms of medication abortion. Misoprostol, which is used in conjunction with Mifepristone, is still available. However, it's technically not approved by the FDA to be used for abortions on its own.
According to The Washington Post on Friday, "The Biden administration will probably appeal to the U.S. Court of Appeals for the 5th Circuit, and the case could make its way to the Supreme Court."
The decision stems from a lawsuit filed last November by the Alliance for Hippocratic Medicine, an anti-abortion group which proposes that the longstanding approval of mifepristone should be revoked because it was allegedly based on incomplete data. The anti-abortion organization Alliance for Hippocratic Medicine claimed that the FDA failed to protect women when it approved the drug.
"The lawsuit alleges that the side effects of mifepristone were not reported adequately 23 years ago when they were reported to the FDA, or that there are more side effects," Seema Mohapatra, a professor of law at SMU Dedman School of Law, explained to Salon. "That is actually scientifically disputed, there are tons of studies showing how safe and effective mifepristone is."
The nation was expecting the decision to be made in February. However, the American College of Obstetricians and Gynecologists, the American Medical Association and the Society for Maternal-Fetal Medicine, and nine other prominent medical organizations submitted an amicus brief including a list of evidence that shows mifepristone is safe and effective.
"Medication abortion including mifepristone is safe and effective," the brief states. "This is not an opinion—it is a fact based on hundreds of medical studies and vast amounts of data amassed over the course of two decades; the FDA based its initial approval on robust evidence which showed mifepristone was extremely safe."
In 2020, medication abortions accounted for nearly 53 percent of all abortions in the United States; 98% of medication abortions used a regimen of mifepristone and misoprostol. Without nationwide access to mifepristone, Guttmacher Institute estimates that abortion access will be even more restrictive to at least 2.4 million women across the country. As of March 12, 2023, abortions were highly restrictive, if not nearly entirely banned, in 12 states. Guttmacher Institute predicts that procedural abortions will rise amid the mifepristone ban where abortions are still legal.
"Without medication abortion using mifepristone as an option, demand for procedural abortions could increase significantly—leading to overwhelmed clinics and providers, much longer wait times, further unnecessary delays, and more complicated and costly logistics for many patients," the Guttmacher Institute said in a recent updated analysis predicting the outcome. "It would be difficult, if not outright impossible, for providers that only offer medication abortion using mifepristone to switch to offering procedural abortions instead."
The Guttmacher Institute added: "Some of these providers will pivot to offering medication abortion using only misoprostol, while others will be forced to stop offering abortion services entirely."
Medication abortions often occur through the brand name drug Mifeprex, which has been approved by the FDA for use for more than 20 years. In this two-step process, a pregnant person first takes a mifepristone pill which block progesterone, a hormone needed to support pregnancy. Either 24 to 48 hours later, a second pill containing misoprostol is taken, which is used to contract and dilate the cervix to expel the embryo. Medication abortion works up to 70 days after the first day of a person's last period — usually when they are 10 weeks pregnant.
"Medication abortion using mifepristone offers several benefits that might make it a preferable option over procedural abortion for people with few financial resources," Guttmacher Institute stated. "Banning mifepristone and potentially forcing patients to receive in-clinic procedural abortion care would create significant additional burdens that could delay or deny care."
"Today's decision is a disaster for the American people," Protect Our Care Chair Leslie Dach said in a statement on Friday. "We are talking about a right-wing judge overruling the opinion of top scientists and other medical experts at the FDA. Taking away a safe, effective medication for abortion is dangerous, especially for rural women, people of color, and other vulnerable groups. This decision also means that judges now have the power to rip away other medications at the whim of their political motivations. This ruling must not stand."
