Texas abortion pill case: Lawyers requesting mifepristone’s removal from market concede there’s no precedent

Boxes of the drug mifepristone line a shelf at the West Alabama Women's Center in Tuscaloosa, Ala.
Boxes of the drug mifepristone line a shelf at the West Alabama Women's Center in Tuscaloosa, Ala.Allen G. Breed, File/AP
  • A federal judge on Wednesday acknowledged the unprecedented nature of an anti-abortion lawsuit.

  • A Texas lawsuit has demanded that the judge revoke the FDA approval of the abortion pill mifepristone.

  • One lawyer conceded he could not name an example of a court intervening in such a way.

A federal judge in Texas heard arguments on Wednesday both for and against the US Food and Drug Administration's approval of the abortion medication mifepristone, in a major legal challenge that threatens access to the drug nationwide.

The legal group Alliance Defending Freedom, which opposes abortion, filed a lawsuit demanding that Judge Matthew Kacsmaryk suspend or revoke the Food and Drug Administration's 20-year-old approval of mifepristone, which has been used widely in conjunction with the drug misoprostol to terminate pregnancies.

The group alleged in their lawsuit that the FDA approved an "unsafe" drug back in 2000. Meanwhile, the US government has argued that overwhelming evidence and numerous studies have shown mifepristone to be safe.

During Wednesday's hearing, The Washington Post and Associated Press reported that all parties acknowledged the unprecedented nature of the Alliance Defending Freedom's demand. Revoking the FDA's approval of mifepristone could immediately upend reproductive care for countless women — recent research indicates that more than half of all abortions in the US are medication abortions.

Kacsmaryk even asked the group to name an "analogue where courts have intervened in such a way," meaning revoked the FDA's approval of a long-established drug on the market.

The attorney representing the Alliance Defending Freedom, Erik Baptist, responded, "No, I can't."

Drugs like mifepristone and misoprostol have been thrown into the spotlight ever since the Supreme Court overturned Roe v. Wade last June. Anti-abortion activists and lawmakers have sought to limit access to the drugs, while their opponents — including the Biden administration — have sought to expand access.

Mifepristone is most commonly used as the first part of a two-step process to terminate pregnancies. Patients typically take a mifepristone pill, which blocks the hormone progesterone and ends the pregnancy, and follow it up 24 to 48 hours later with misoprostol pills, which induce contractions.

During Wednesday's hearing, Kacsmaryk noted he would issue a ruling as soon as possible, according to the Post.

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