The future of mifepristone, a widely used abortion drug in the United States for over 20 years, hangs in the balance as the manufacturer seeks a decision from the U.S. Supreme Court.
Danco Laboratories has requested the Supreme Court to reverse a lower court’s ruling that would restrict access to the medication across the country. Currently, the ruling is on hold.
If the Supreme Court agrees to hear the case in the upcoming fall session, a decision will likely be reached in 2024, just months before the next presidential election. The court’s previous decision to overturn Roe v. Wade in 2021 was believed to have fueled significant voter turnout in the 2022 midterm elections.
Despite evidence of the safety and effectiveness of mifepristone, lower federal courts have sided with a conservative coalition that challenges the Food and Drug Administration’s approval of the drug.
In 2000, the FDA initially approved mifepristone following an extensive and expert-led approval process. In 2016 and 2021, the agency made adjustments to remove certain barriers to access, allowing pregnant patients to obtain the drug through telehealth appointments if desired. Mifepristone is typically prescribed as part of a two-drug regimen to terminate a pregnancy, with misoprostol being the other drug.
However, in April, a federal judge in Texas ruled in favor of abortion opponents who sued the FDA over its approval of mifepristone. U.S. District Judge Matt Kacsmaryk stated that the agency had manipulated the drug approval process to enable widespread chemical abortions, using language similar to that of anti-abortion activists.
The case was appealed and brought before the conservative U.S. Court of Appeals for the 5th Circuit. While two of the three judges on the panel favored rolling back the FDA’s actions in 2016 and 2021, Judge James Ho went even further, advocating for the removal of FDA approval, echoing Judge Kacsmaryk’s stance.
While Judge Kacsmaryk believed the FDA’s approval was initially incorrect, the 5th Circuit judges thought the agency’s actions in 2016 and 2021 were the main issue. If their ruling is upheld, access to mifepristone will be restricted to the guidelines from before 2016.
This would increase the challenges for pregnant patients seeking the pill, as it would require multiple in-person doctor’s appointments and limit the window for prescribing the medicine.
Danco Laboratories is now asking the Supreme Court to consider whether the anti-abortion coalition had legal standing to bring the lawsuit and if the 5th Circuit made errors in its judgment.
While two of the three 5th Circuit judges favored rolling back mifepristone access to the pre-2016 guidelines, Judge James Ho went even further, proposing the removal of FDA approval, aligning with Judge Kacsmaryk.
(Judge Ho and Judge Kacsmaryk participated in a panel discussion hosted by the Federalist Society in Texas during the summer.)
Judge Ho, who was sworn in by Supreme Court Justice Clarence Thomas at the home of Republican mega-donor Harlan Crow, argued that doctors experience “an aesthetic injury” when a patient terminates their pregnancy, as “unborn babies are a source of profound joy for those who view them.”
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