SCOTUS pauses ban on abortion pill for now

(AP Photo/Charlie Neibergall)

Supreme Court Justice Samuel Alito issued a brief order Wednesday afternoon that paused the ban on the sale of mifepristone through Friday evening. This gives the court additional time to consider the case.

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Earlier this month, U.S. District Judge Matthew J. Kacsmaryk ruled in Texas in agreement with conservative groups challenging the FDA’s approval of mifepristone as safe and effective. Kacsmaryk issued a 67-page opinion. As I wrote at the time, he didn’t want to second-guess the FDA’s decision but he had safety concerns.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”

Justice Alito announced the court extended a pause on Kacsmaryk’s ruling that invalidated the FDA’s approval of the abortion pill. The pill was first approved in 2000. Mifepristone will remain available in states that allow its sale, at least until Friday evening.

Mifepristone is one of two abortion drugs used in a two-step process for medication abortion, as it is called. More than half of all abortions in the United States are medication abortions. Mifepristone is considered safe and popular. This case is the most significant abortion case since the Dobbs ruling that sent abortion back to the States last summer.

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DOJ and Danco Laboratories, the maker of mifepristone, asked the Supreme Court to put the full decision from Judge Kacsmaryk on hold. Solicitor General Elizabeth Prelogar also asked the court to leave mifepristone available for sale while the case worked its way through the court process. At the time of Kacsmaryk’s ruling, U.S. District Judge Thomas O. Rice in Washington State countered with a ruling to preserve the status quo and continue access in the 17 states, including D.C., that are involved in the second lawsuit that seeks to protect the abortion medicine. So the confusion grows with this short, temporary move by Justice Alito.

The company that makes the generic version of mifepristone, GenBioPro, sued the FDA. It seeks to block the FDA from complying if the drug is ultimately ordered off the market. The move is yet another layer to the story.

GenBioPro brought the case against the FDA in U.S. District Court in Maryland after orders by a federal court judge in Texas and a court of appeals this month required the agency to revoke its approval of generic mifepristone. The company cited court filings in which the FDA indicated that, barring a stay by the Supreme Court, it would comply with the rulings by deeming GenBioPro’s mifepristone “misbranded,” which means the drug would have to be pulled from distribution.

GenBioPro contends that by complying with the court orders, the FDA would be violating laws and procedures approved by Congress that dictate the means for withdrawing prior approval of a drug.

“In the United States, once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug. GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers,” GenBioPro CEO Evan Massingill said in a statement.

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So, here we are. The drug is still available for sale in states that permit it and a final ruling won’t come until Friday evening, if then. The status quo is maintained for now.

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