The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA’s medical approval of mifepristone, which might effectively ban the abortion pill across the US.
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A Texas judge will soon issue a pivotal ruling in a closely watched case difficult the Food and Drug Administration’s approval of the abortion pill mifepristone.
The lawsuit filed by a gaggle 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 numerous alternative ways.
He could order the FDA to drag mifepristone from the U.S. market entirely. It is also possible that Kacsmaryk could order the agency to impose tighter restrictions on access to mifepristone but stop wanting completely halting sales. The judge could also rule within the FDA’s favor, however the anti-abortion groups would appeal.
Kacsmaryk told the attorneys involved within the case during oral arguments in Amarillo on Wednesday that he’ll 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 best impact in states where abortion stays legal, said Carrie Flaxman, who heads litigation on the Planned Parenthood Federation of America.
Rachel Rebouche, an authority on reproductive health law at Temple University, said an order blocking sales would create confusion because there might 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 may very well be drafted. The impact of his decision will depend upon the language of the order and the way the FDA chooses to reply.
“There are quite a lot of ways the court could effectuate a choice in our favor,” said Erik Baptist, who’s representing the Alliance for Hippocratic Medicine within the case and is the senior counsel on the Alliance Defending Freedom, one other 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 drag mifepristone from the U.S. market.
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“But how the court effectuates when it comes to timing – does it go into effect immediately, does it go into effect in 30 days, again that is inside the court’s discretion,” Baptist said.
Rebouche said it’s possible the judge issues a ruling that orders the FDA to start out the technique of withdrawing mifepristone while at the identical time suspending the drug from the market because the agency conducts that process.
Swift appeal
If Kacsmaryk issues an order to withdraw mifepristone immediately, the Biden administration would ask him to pause the choice pending its appeal, said Glenn Cohen, an authority on health law at Harvard. If Kacsmaryk refuses, the administration will take the case to the fifth U.S. Circuit Court of Appeals.
“My guess is stay papers are already drafted. Someone will put them before the court inside hours of the choice,” said Cohen, who previously served as a lawyer within the Justice Department’s civil division.
Cohen, Rebouche and 17 other drug law experts, in a filing submitted to the court in support of the FDA, told Kacsmaryk that ordering a right away withdrawal of mifepristone would conflict with federal law.
The authority to withdraw a drug resides with the FDA commissioner who makes that call based on scientific evidence on the drug’s safety and efficacy, they said. The manufacturer, on this case Danco Laboratories, can be speculated to get a hearing in the course of the process.
“The FDA would argue the court cannot withdraw the drug — the FDA has to withdraw the drug and the court is preempted by federal statue from withdrawing the drug,” said Rebouche.
FDA could drag out the method
If Kacsmaryk decides against a right away withdraw of mifepristone and as a substitute orders the FDA to initiate its formal process to drag the drug from the market, the agency can use the method to stonewall assuming he doesn’t suspend the approval during that point,
“The withdrawal of a drug from the market when the FDA follows those procedures takes months if not years, so the FDA could try to attract out the method a little bit bit longer to maintain the drug in the marketplace within the meantime,” said Allison Whelan, an authority on FDA law at Georgia State University.
“The FDA doesn’t like its scientific expertise and legitimacy to be called into query,” said Whelan, who also signed the filing to the court in support of the FDA.
Mifepristone off-label
The agency also has enforcement discretion under which it may well decide to not go after corporations that sell unapproved drugs, Whelan said. Mifepristone can be approved to treat a condition called Cushing’s syndrome. Some clinics could resolve to prescribe the pill off-label for abortions, she said.
And mifepristone is utilized in a two-drug regimen with one other medication called misoprostol. Baptist with the Alliance Defending Freedom told reporters in the course of the Thursday news conference that the lawsuit is simply targeting the approval of mifepristone.
Misoprostol is really helpful 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 by itself, clinics are planning on using the that pill as a substitute for mifepristone.
The American College of Obstetricians and Gynecologists recommends misoprostol instead for early abortions if mifepristone shouldn’t be available, though it isn’t as effective because the two-drug regimen, in line with the organization.
Tougher restrictions
Kacsmaryk could also stop wanting halting mifepristone sales and as a substitute order the FDA to impose tougher restrictions on how the medication is distributed.
In January, the FDA permanently lifted a requirement that patients obtain mifepristone in person from a licensed health-care provider. This allowed telehealth appointments and delivery of mifepristone by mail.
The Alliance for Hippocratic Medicine has asked the judge to reimpose FDA restrictions which have been rolled back over time, arguing that a federal statue from 1873 called the Comstock Act bans sending abortion medication via mail.
Rebouche said the Comstock Act hasn’t been enforced in a long time, but there is a possibility that the judge could attempt to revive the statue to force the FDA to reimpose requirements that patients obtain mifepristone in person.
Correction: Allison Whelan is an authority on FDA law at Georgia State University. An earlier version misstated the name of the college.
