Federal Judge Pauses Lawsuit Challenging FDA Approval of Abortion Pill

A federal judge has agreed to a U.S. Food and Drug Administration request to pause a lawsuit over the safety of the mifepristone pill.

U.S. District ‌Judge Reed O'Connor in Fort Worth, Texas, said on Aug. 31 that the lawsuit would be delayed until President Donald Trump’s administration completes a review of the drug’s safety or until Dec. 1, whichever comes first.

O'Connor rejected a motion by drugmakers GenBioPro and Danco Laboratories, which make mifepristone and have intervened in the ⁠lawsuit, to dismiss the case.

The lawsuit said that under federal law, the purpose of the FDA is to ensure that drugs on the “market are safe and effective.”

The plaintiffs—the State of Florida and the State of Texas—allege that the FDA has “contravened that purpose” by taking unlawful agency action concerning mifepristone and misoprostol.

The filing went into detail about how these drugs accomplish chemical abortions.

It said that mifepristone blocks progesterone receptors in the uterus, causing the uterine lining to break down. Without this lining providing necessary sustenance to the baby, the baby dies.

The lawsuit, filed last December, challenges the FDA’s approval of mifepristone in 2000, which has gradually expanded access, including under a Biden-era policy allowing the drug to be prescribed and dispensed by mail.

GenBioPro CEO Evan Masingill ​said in a statement that the company expects the FDA to uphold previous findings that its products are “safe and ​effective.”

“Ensuring legal access to mifepristone in the long term is vital ​to women’s healthcare and reproductive freedom,” he said.

The FDA said in an April 8 update that it has been moving ahead with a safety study of mifepristone.

It said that once the FDA finishes its analysis of the data, the agency will “decide whether to make substantive changes” to the Risk Evaluation and Mitigation Strategy (REMS).

A drug is placed on a REMS program to ensure that the benefits of the drug outweigh its risks.

It said that if the FDA determines “that changes to the REMS are warranted, then the agency will take appropriate action.”

After the Supreme Court held that the Constitution does not protect the right to abortion in 2022, about 13 states enacted near-total bans and several more imposed six-week limits.

Five states have filed three separate lawsuits, which generally claim the FDA has failed to thoroughly evaluate the safety and effectiveness of mifepristone since its initial approval and ‌disregarded the risks to the women who take it.

National Right to Life, the country’s largest national anti-abortion organization, said in a July 27 statement that the court had simply told the FDA to “explain itself more fully.”

“That is far different from proving that the restrictions lack a medical purpose,” it said.

“The claim that mifepristone is ‘exceedingly safe’ also deserves scrutiny. A 2023 population-based study of women in Ontario, published in the Annals of Internal Medicine, found that 10.3 percent of women who underwent chemical abortions visited an emergency department afterward.”

It said that mifepristone works by blocking progesterone, the hormone that sustains pregnancy.

“Misoprostol then causes contractions to expel the developing child,” it stated.

“The regimen does not merely carry a risk of ending a human life. Ending that life is its intended purpose. No discussion of ‘safety’ can honestly ignore the unborn child. A successful chemical abortion always ends in death for that child.”

Reuters contributed to this report.