In the latest blow to reproductive rights, a federal judge in Texas has halted the FDA’s approval of mifepristone, one of two drugs used in medication abortions in the United States. Here’s what this unprecedented ruling could mean for the future of abortion pill access nationwide.
Late last week, U.S. District Judge Matthew Kacsmaryk — an ultra-conservative Trump-era appointee — ruled in favor of anti-abortion advocates in Texas who baselessly contested the FDA’s longstanding approval of mifepristone. For more than 20 years, this pill has been used to safely and effectively terminate pregnancies, often with the drug misoprostol for a two-step protocol.
“This is the first time in history that a judge has stayed an approval of a human drug over the objection of the FDA,” law professor Greer Donley told Abortion, Every Day. “There is a reason for this: when it comes to determinations of drug safety and efficacy, most Americans would rather have expert scientists and doctors make those decisions, not politically motivated judges.”
As CBS News reported, Kacsmaryk’s decision fell short of completely withdrawing the FDA’s approval. Still, the ruling could create barriers for people who need mifepristone throughout the country, including in pro-choice states.
Kacsmaryk’s ruling will take effect this Friday, April 14. The Biden administration has already filed an appeal.
“The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk,” said President Joe Biden in a statement.
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Planned Parenthood called the decision “unprecedented and harmful.” Senior executives from the country’s leading drug companies also issued a searing condemnation of the ruling, claiming it undermines the FDA’s authority and “creates uncertainty for the entire biopharma industry.”
Indeed, this decision presents a number of problems. For one thing, it stands in direct opposition to another recent ruling in Washington state, where a federal judge opined that the FDA shouldn’t restrict access to mifepristone. Given the contradictory nature of these rulings, the Supreme Court may have to intervene.
It also poses yet another obstacle for pregnant people who need abortions in post-Roe v. Wade America. The vast majority of U.S. abortions are performed non-surgically using mifepristone and/or misoprostol.
Mifepristone is sometimes prescribed to people who have had miscarriages or have Cushing’s syndrome, a hormonal condition, so taking it off the market would have ripple effects beyond the context of abortions.
Worth noting, too, is that pregnant people can have a safe, effective medication abortion using only misoprostol, which is not implicated in Kacsmaryk’s ruling. The misoprostol-only protocol just looks a bit different. So, while this unprecedented decision is alarming, banning mifepristone would not mean the end of medication abortions in the U.S.
Since Roe fell last June, at least 17 states have banned or severely restricted access to abortions — including Texas, which began enforcing a near-total abortion ban in August.
According to a JAMA report from 2022, one-third of Americans who can get pregnant now have to travel more than an hour away to reach their nearest abortion provider.
Before you go, check out these powerful stories from celebrities who opened up about getting abortions:
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