A US judge in Texas will soon rule on the abortion pill mifepristone. Here’s what can happen

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The Alliance for Hippocratic Medicine wants Judge Kacsmaryk to overturn the FDA’s medical approval of mifepristone, which would effectively ban the abortion pill in the US.

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A Texas judge is about to issue a key ruling in a closely watched case challenging the Food and Drug Administration’s approval of the abortion pill mifepristone.

The lawsuit, filed by an anti-abortion group of doctors called the Alliance for Hippocratic Medicine, is an unprecedented case, and Judge Matthew Kacsmaryk of the U.S. Northern District of Texas could rule in several different ways.

He could order the FDA to pull mifepristone off the US market entirely. It’s also possible that Kacsmaryk would order the agency to impose tighter restrictions on access to mifepristone, but not stop sales entirely. A judge could also rule in favor of the FDA, but anti-abortion groups would appeal.

Kacsmaryk told lawyers involved in the case during oral arguments in Amarillo on Wednesday that he would issue his decision “as soon as possible.”

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Abortion rights groups and legal experts expect the judge to rule against the FDA in some form. Kacsmaryk joined the court in 2019 after being appointed by the previous president Donald Trump. His nomination was unanimously opposed by Senate Democrats and Republican Susan Collins of Maine over concerns about his views on abortion and LGBTQ rights.

Wendy Davis, senior counsel for Planned Parenthood Texas Votes, told reporters at a news conference Wednesday that abortion rights activists are preparing for the worst.

A court order blocking the sale of mifepristone would have the biggest impact in states where abortion is still legal, said Carrie Flaxman, who leads litigation at Planned Parenthood of America.

Rachel Rebouche, an expert on reproductive health law at Temple University, said an order blocking the sale would cause confusion as there would be further litigation over whether such an order is legal.

Possible injunction

If Kacsmaryk issues an order to withdraw mifepristone from the market, there are several ways to prepare such a decision. The impact of his decision will depend on the language of the order and how the FDA chooses to respond.

“There are a lot of ways the court could enforce a decision in our favor,” said Erik Baptist, who represents the Alliance for Hippocratic Medicine in the case and is senior counsel for Alliance Defending Freedom, another anti-abortion group.

Baptist told reporters during Thursday’s news conference that a judge could immediately overturn the FDA’s approval or order the agency to initiate proceedings to withdraw mifepristone from the U.S. market.

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“But how the court goes into effect in terms of the timing — whether it goes into effect immediately, or whether it goes into effect in 30 days, is again at the discretion of the court,” Baptist said.

Rebouche said it’s possible a judge could issue a ruling ordering the FDA to begin the process of withdrawing mifepristone, while suspending the drug from the market while the agency conducts that process.

Quick appeal

If Kacsmaryk orders the immediate withdrawal of mifepristone, the Biden administration would ask him to suspend the decision pending an appeal, said Glenn Cohen, a health law expert at Harvard. If Kacsmaryk refuses, the administration will take the case to the 5th U.S. Circuit Court of Appeals.

“My guess is that the prison documents are ready. Someone will be submitting them to the court within hours of the decision,” said Cohen, who previously worked as an attorney in the Justice Department’s civil division.

In a court filing in support of the FDA, Cohen, Rebouche and 17 other drug law experts told Kacsmaryk that an order to immediately withdraw mifepristone would violate federal law.

The authority to withdraw a drug rests with the FDA commissioner, who makes that decision based on scientific evidence of the drug’s safety and effectiveness, they said. The manufacturer, in this case Danco Laboratories, should also be questioned during the process.

“The FDA would argue that a court can’t pull a drug — the FDA has to pull the drug and the federal statute gives the court preemption to pull the drug,” Rebouche said.

The FDA could delay the process

If Kacsmaryk decides against withdrawing mifepristone immediately and instead orders the FDA to initiate a formal process to withdraw the drug from the market. Assuming it doesn’t suspend the approval during that time, the agency can use the suppression process.

“Taking a drug off the market when the FDA follows these processes takes months, if not years, so the FDA could try to drag out the process a bit longer to keep the drug on the market in the meantime,” said Allison Whelan. , an FDA law expert at George State University.

“The FDA does not want its scientific expertise and legitimacy to be called into question,” said Whelan, who also signed the court filing in support of the FDA.

Mifepristone is not approved

Tighter restrictions

Kacsmaryk could also stop short of halting the sale of mifepristone and instead order the FDA to impose tighter restrictions on the drug’s distribution.

In January, the FDA permanently removed the requirement that patients receive mifepristone in person from a certified health care provider. This has enabled the ordering of telehealth examinations and the delivery of mifepristone by mail.

The Hippocratic Medicine Association asked a judge to reinstate the FDA’s restrictions, which have been overturned over the years, arguing that an 1873 federal statute called the Comstock Act prohibits abortion drugs from being sent through the mail.

Rebouche said the Comstock Act hasn’t been enforced in decades, but there’s a chance a judge could try to revive the statue, forcing the FDA to reinstate requirements that patients receive mifepristone in person.

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