
In 2022, several pro-life groups and individuals, represented by the Alliance Defending Freedom (ADF), sued the FDA arguing that the administration failed to use the proper channels and hurriedly approve the drug in 2000, without weighing its severe risks to women, which include heavy bleeding, loss of future fertility and even deaths in some cases.
ADF Senior Counsel Erin Hawley reacted to the news in a Wednesday statement in which she urged the Supreme Court to uphold “common-sense safeguards” around Mifepristone.
“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions. We urge the Supreme Court to do the same,” Hawley said.
Texas federal district judge Matthew Kacsmaryk issued a ruling in April of this year that entirely invalidated the FDA’s Mifepristone approval. That decision, subsequently overturned by higher courts, would have essentially made the abortion pill illegal.
The most recent ruling in AHM v. FDA by the U.S. 5th Circuit Court of Appeals invalidated the FDA’s post-2016 rule changes to Mifepristone. This means that pre-2016 restrictions on abortion drugs, which included a ban on mailing them or administering them via telemedicine (without an in-person doctor’s visit), would be reinstated.
The 5th Circuit said in its ruling that the FDA failed to “consider the cumulative effect of removing several important safeguards” and “to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”