Judge pauses state’s abortion pill lawsuit until FDA completes timely safety review

A federal judge on April 7 paused Louisiana’s lawsuit challenging the U.S. Food and Drug Administration’s approval of mifepristone pending its promised safety review.

But the judge also indicated the state could continue its challenge after that review.

U.S. District Judge David Joseph in Lafayette, Louisiana, said that the state’s challenge to a 2023 rule allowing mifepristone to be dispensed by mail should not proceed until the FDA conducts its promised safety review and indicates whether it will seek to repeal the regulation.

“At this juncture, it is the completion of FDA’s promised good faith, evidence-based, and expeditious review of the mifepristone REMS, not ‘government by lawsuit’ that this Court finds to be in the public interest,” Joseph wrote, referring to the FDA’s current Risk Evaluation and Mitigation Strategies governing mifepristone.

Previously, Louisiana Attorney General Liz Murrill, alongside Rosalie Markezich, who said she was coerced into taking abortifacient drugs by her then-boyfriend, sued the FDA over a policy permitting mifepristone, a drug commonly but not exclusively used for early abortion, to be distributed by mail. The suit contends the policy enabled Markezich’s former partner to acquire the drug from a California doctor, whom Markezich says never spoke with her, and then coerced her into taking it.

Under the Trump administration, the U.S. Department of Justice asked the court to pause Louisiana’s lawsuit, as well as similar efforts in other states, which sought to roll back the Biden administration’s eased restrictions on mifepristone. DOJ lawyers argued in their filings that the court “should either stay this case until after FDA completes its review or dismiss it.”

This provoked frustration from some pro-life leaders who argued the Trump DOJ was undermining state efforts to protect women and unborn children.

Although Joseph denied Louisiana’s request to block the regulation that permits mifepristone to be dispensed by mail, he indicated that the state could renew its case after the review.

However, the status and timeline of the FDA’s review are unclear. A spokesperson for the Department of Health and Human Services, which oversees the FDA, said in a written statement provided to OSV News, “The FDA is conducting its safety study of mifepristone, including the collection of robust and timely data, evaluation of data integrity, and implementation of the analyses, validation, and peer-review.”

“Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes to the (Mifepristone Risk Evaluation and Mitigation Strategy),” the spokesperson said April 8. “The agency is taking care to do this study properly and in the right way. We are planning to complete the study as soon as possible while ensuring we are not cutting any corners from a scientific research standpoint.”

The spokesperson said such studies “often take approximately a year or more to conduct,” but they plan “to have this study done sooner than that timeframe.”

“Drug safety is a paramount issue with all drugs that the agency approves,” the statement said.

But Joseph wrote that the stay he granted to the FDA “will not remain open-ended.”

“FDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged,” he wrote. “The parties and the American public deserve nothing less.”

Should the FDA fail to complete its review and make any necessary revisions to the mifepristone REMS “within a reasonable timeframe,” he added, “the Court’s analysis — and the weight accorded to these factors — will inevitably change.”

In an April 8 statement, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, argued that the judge’s ruling vindicated Louisiana’s right to bring the lawsuit forward.

“This ruling comes after the DOJ has repeatedly tried to get states’ challenges to the policy dismissed, even while online abortion drug vendors flagrantly violate state laws and send women and girls to emergency rooms across the country,” she said. “The Trump-Vance administration should stand with Louisiana and other states to enforce their laws and protect women and unborn children, rather than defending Biden’s disastrous COVID-era policies.”

Dannenfelser added, “It is urgent that the FDA complete its promised safety study on these drugs, but this study also should not delay commonsense action: Deadly abortion drugs do not belong in the mail with no in-person doctor visit, no ultrasound, no meaningful medical oversight and no accountability.”

Proponents of the drug argue it is statistically safe for a woman to take, and attempts to restrict it are an attempt to ban abortion outright. In contrast, opponents argue there are significant risks to those who take it, particularly outside of medical settings, in addition to ending the life of an unborn child early in its development.

The FDA under the second Trump administration also recently approved a new generic for mifepristone, commonly known as the “abortion pill,” an action that frustrated pro-life leaders as the first Trump administration also approved the drug’s first generic.

Bishop Daniel E. Thomas of Toledo, Ohio, chair of the U.S. Conference of Catholic Bishops’ Committee on Pro-Life Activities, recently offered his support to legislation that would revoke the FDA’s approval of mifepristone for abortions. However, that bill faces long odds in Congress.

The Catholic Church teaches that all human life is sacred from conception to natural death, and as such, opposes direct abortion. After the 2022 Dobbs v. Jackson Women’s Health Organization decision, Church leaders in the U.S. have reiterated the Church’s concern for both mother and child and have called to strengthen available support for those living in poverty or other circumstances that can increase the risk of abortion.

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