Federal Appeals Court Restricts Access to Abortion Medication Due to Improper Process
A federal appeals court has announced that it will restrict access to a widely used abortion medication after determining that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available. The U.S. Court of Appeals for the 5th Circuit, a conservative three-judge panel, found that the Food and Drug Administration (FDA) decisions to allow the drug mifepristone to be taken later in pregnancy, be mailed directly to patients, and be prescribed by a medical professional other than a doctor were not lawful.
While the litigation continues, mifepristone will remain available under existing regulations, in accordance with a Supreme Court ruling earlier this year. However, if the appeals court ruling eventually takes effect, it would make it more difficult for patients to access the abortion pill in the United States.
The court’s decision partially upheld a lower-court judge’s ruling in favor of a coalition of anti-abortion challengers. The ruling can be appealed to the Supreme Court. The Alliance for Hippocratic Medicine, an association of anti-abortion doctors and others, brought the challenge to mifepristone. The group argued that the FDA did not adequately consider safety concerns when approving the drug in 2000 or when removing some restrictions in subsequent years.
The challengers contended that the abortion pill should never have been approved and should be removed entirely from the market. The lawsuit was filed in Amarillo, Texas, where U.S. District Judge Matthew Kacsmaryk, a Trump nominee with anti-abortion views, is the sole sitting judge. In April, Kacsmaryk issued a ruling suspending FDA approval of a human drug for the first time, using language favored by anti-abortion activists.
Two of the three judges on the appeals court did not go as far as Kacsmaryk in their opinion. They ruled that too much time had passed for the challengers to mount a court challenge to the FDA’s 2000 approval of mifepristone. However, they did rule that the agency did not properly vet whether the medication would still be safe if not administered in-person.
The Justice Department, representing the FDA, and the drug manufacturer Danco Laboratories have emphasized the FDA’s reliance on numerous studies involving thousands of patients to approve the medication. They argue that serious side effects occur in fewer than 1 percent of patients. Lawyers defending the drug also argued that the anti-abortion challengers had no legal right or standing to file the lawsuit since they were not directly harmed by the FDA’s approval of the abortion pill.
The Supreme Court temporarily put a previous appeals court decision on hold, leaving the current FDA regulations for mifepristone in place while the litigation continues. Judge James C. Ho dissented from part of the appeals court’s opinion, stating that he believes the statute of limitations for challenging the initial approval of mifepristone has not lapsed and that the challengers have standing to contest it.
The U.S. fight over abortion continues to intensify following the Supreme Court’s decision to overturn Roe v. Wade’s grant of a constitutional right to abortion in June 2022. This decision has prompted multiple states to further restrict or ban the procedure. The outcome of this ongoing litigation will have significant implications for access to abortion medication in the United States.
This is a developing story and will be updated as more information becomes available.
What were the safety concerns mentioned in the lawsuit challenging mifepristone’s accessibility?
Access to mifepristone, citing safety concerns.
The appeals court’s decision comes after a lengthy legal battle over the regulations surrounding mifepristone, a medication commonly used to induce abortions in the early stages of pregnancy. In 2016, the FDA made changes to its regulations to make the pill more accessible, allowing it to be taken later in pregnancy, mailed directly to patients, and prescribed by medical professionals other than doctors. However, the appeals court has now determined that these changes were not made through the proper process and therefore are not lawful.
While the litigation continues, mifepristone will still be available under the existing regulations, thanks to a ruling by the Supreme Court earlier this year. However, if the appeals court ruling eventually goes into effect, it will become more difficult for patients to access the abortion pill in the United States.
The appeals court’s decision partially upholds a ruling by a lower-court judge in favor of a coalition of anti-abortion challengers. This ruling can still be appealed to the Supreme Court. The Alliance for Hippocratic Medicine, a group of anti-abortion doctors and others, brought the challenge to mifepristone, arguing that the FDA did not adequately consider safety concerns when approving the drug in 2000 or when easing some restrictions in subsequent years.
The challengers’ main argument is that the abortion pill should never have been approved and should be completely removed from the market. The lawsuit was filed in Amarillo, Texas, where U.S. District Judge Matthew Kacsmaryk, a Trump nominee known for his anti-abortion views, presides. In April, Kacsmaryk issued a ruling that temporarily suspended access to mifepristone, citing safety concerns.
This is a concerning setback for women’s reproductive rights.
The court’s decision seems to prioritize administrative procedures over women’s healthcare needs.