U.S. judge in Texas will soon rule on the abortion pill mifepristone. Here’s what could happen
A Texas judge will soon issue a pivotal ruling in a closely watched case challenging the Food and Drug Administration’s approval of the abortion pill mifepristone.
The lawsuit filed by a group of doctors who oppose abortion, 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 a number of different ways.
He could order the FDA to pull mifepristone from the U.S. market entirely. It’s also possible that Kacsmaryk could order the agency to impose tighter restrictions on access to mifepristone but stop short of completely halting sales. The judge could also rule in the FDA’s favor, but the anti-abortion groups would appeal.
Kacsmaryk told the attorneys involved in the case during oral arguments in Amarillo on Wednesday that he will issue his decision “as soon as possible.”
Abortion rights groups and legal experts expect the judge will rule against the FDA in some form. Kacsmaryk joined the court in 2019 after he was appointed by former President Donald Trump. His nomination was unanimously opposed by Senate Democrats as well Republican Susan Collins of Maine over concerns about his views on abortion and LGBTQ rights.
Wendy Davis, senior advisor at Planned Parenthood Texas Votes, told reporters at a news conference Wednesday that abortion rights activists are preparing for the worst.
A court order that blocks sales of mifepristone would have the greatest impact in states where abortion remains legal, said Carrie Flaxman, who heads litigation at the Planned Parenthood Federation of America.
Rachel Rebouche, an expert on reproductive health law at Temple University, said an order blocking sales would create confusion because there will 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 such a ruling could be drafted. 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 effectuate a decision in our favor,” said Erik Baptist, who is representing the Alliance for Hippocratic Medicine in the case and is the senior counsel at the Alliance Defending Freedom, another anti-abortion group.
Baptist told reporters during a news conference Thursday the judge could overturn the FDA’s approval immediately or he could order the agency to initiate a process to pull mifepristone from the U.S. market.
Mifepristone off-label
The agency also has enforcement discretion under which it can choose to not go after companies that sell unapproved drugs, Whelan said. Mifepristone is also approved to treat a condition called Cushing’s syndrome. Some clinics could decide to prescribe the pill off-label for abortions, she said.
And mifepristone is used in a two-drug regimen with another medication called misoprostol. Baptist with the Alliance Defending Freedom told reporters during the Thursday news conference that the lawsuit is only targeting the approval of mifepristone.
Misoprostol is recommended as a stand-alone method to terminate a pregnancy by the World Health Organization. Although the FDA has not approved misoprostol as an abortion medication on its own, clinics are planning on using the that pill as an alternative to mifepristone.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions if mifepristone is not available, though it’s not as effective as the two-drug regimen, according to the organization.
