The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify 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 crucial ruling in a closely watched case challenging the Food and Drug Administration’s approval of the abortion pill mifepristone.
The lawsuit, brought by a group of anti-abortion doctors called the Alliance for Hippocratic Medicine, is an unprecedented case, and Judge Matthew Kacsmaryk of the US Northern District of Texas could rule in a number of ways.
He could order the FDA to take mifepristone off the US market entirely. It’s also possible that Kacsmaryk could instruct the agency to tighten access to mifepristone, but not stop selling it entirely. The judge could also rule in favor of the FDA, but the anti-abortion groups would appeal.
Kacsmaryk told attorneys involved at the hearing 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 will rule against the FDA in some way. Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. His nomination was unanimously rejected by both Senate Democrats and Maine Republican Susan Collins 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 blocking the sale of mifepristone would have the greatest impact in states where abortion remains legal, said Carrie Flaxman, who is leading the lawsuit at the Planned Parenthood Federation of America.
Rachel Rebouche, a reproductive health law expert at Temple University, said an order blocking sales would create confusion as there will be further litigation over whether such an order is legal.
If Kacsmaryk issues an order to take mifepristone off the market, there are several ways to make such a decision. The impact of his decision will depend on the language of the order and FDA’s response.
“There are many ways the court can bring about a ruling in our favor,” said Erik Baptist, who represents the Alliance for Hippocratic Medicine in the case and is senior counsel at the Alliance Defending Freedom, another anti-abortion group.
Baptist told reporters during a Thursday news conference that the judge could overturn the FDA’s approval immediately or direct the agency to initiate proceedings to remove mifepristone from the US market.
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“But how the court proceeds with respect to the timetable — effective immediately, effective in 30 days, that too is at the court’s discretion,” Baptist said.
Rebouche said it’s possible for the judge to issue a decision directing the FDA to begin the process of withdrawing mifepristone while suspending the drug from the market while the agency conducts that process.
Quick roll call
If Kacsmaryk issues an order to withdraw mifepristone immediately, the Biden administration would ask him to stay the decision pending its appeal, said Harvard health law expert Glenn Cohen. If Kacsmaryk refuses, the administration will take the case to the US 5th Circuit Court of Circuits.
“My guess is that the residence papers have already been drafted. Someone will take them to court within hours of the decision,” said Cohen, who was previously an attorney with the Justice Department’s civil division.
Cohen, Rebouche and 17 other drug law experts told Kacsmaryk in a court-filed filing in support of the FDA that ordering an immediate withdrawal of 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 make itself heard in the process.
“The FDA would argue that the court cannot retract the drug — the FDA must retract the drug, and the court is barred by federal statute from retracting the drug,” Rebouche said.
The FDA could drag out the process
If Kacsmaryk decides against immediately withdrawing mifepristone and instead directs the FDA to begin its formal process to withdraw the drug from the market, the agency can use the process to block it, provided it doesn’t suspend approval during that time .
“Withdrawing a drug from the market when the FDA follows these procedures takes months if not years, so the FDA may try to lengthen the process a little longer to keep the drug on the market in the meantime.” , said Allison Whelan, an FDA law expert at Georgia State University.
“The FDA doesn’t like having its scientific expertise and legitimacy questioned,” said Whelan, who also signed the motion in court in support of the FDA.
Mifepristone off label
The agency also has enforcement discretion, under which it can choose not to prosecute companies that sell unapproved drugs, Whelan said. Mifepristone is also approved to treat a condition called Cushing’s syndrome. Some clinics may choose to prescribe the pill off-label for abortions, she said.
And mifepristone is used in a two-drug regimen with another drug called misoprostol. Baptist, of the Alliance Defending Freedom, told reporters during Thursday’s news conference that the lawsuit only seeks approval for mifepristone.
Misoprostol is recommended by the World Health Organization as a standalone method of terminating pregnancy. Although the FDA has not approved misoprostol as a standalone abortion drug, clinics plan to use this pill as an alternative to mifepristone.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions when mifepristone is unavailable, although it’s not as effective as the two-drug regimen, according to the organization.
Kacsmaryk could also stop halting mifepristone sales and instead direct the FDA to impose tighter restrictions on the drug’s distribution.
In January, the FDA permanently removed the requirement that patients must receive mifepristone in person from a certified healthcare provider. This enabled telemedicine appointments and mail delivery of mifepristone.
The Alliance for Hippocratic Medicine has asked the judge to reinstate FDA restrictions that have been reversed over the years, arguing that an 1873 federal law called the Comstock Act bans the sending of abortion drugs through the mail.
Rebouche said the Comstock Act hasn’t been enforced in decades, but there’s a possibility the judge could try to revive the statue to force the FDA to re-impose requirements that patients receive mifepristone in person.
Correction: Allison Whelan is an FDA law expert at Georgia State University. In an earlier version, the name of the school was given incorrectly.