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In a high-stakes hearing, a judge will consider whether to order an abortion pill off the market

A lawsuit filed in Texas challenges the FDA approval of medications used to terminate a pregnancy. The judge has been asked to halt access to one drug nationwide.
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A federal judge in Texas held a hearing Wednesday in a lawsuit that seeks to overturn the Food and Drug Administration’s approval of the pills used in medication abortions.

The coalition of anti-abortion groups behind the suit, called the Alliance for Hippocratic Medicine, has requested a preliminary injunction to take one of the two drugs, mifepristone, off the market nationwide while the case proceeds.

That request is the focus of Wednesday’s hearing, which began at 9 a.m. local time, though it is not known when U.S. District Judge Matthew Kacsmaryk will issue his decision — it could come later Wednesday or in the following days or weeks.

Image: Lindsay London holds a sign in support of access to abortion medication, outside the Federal Courthouse on March 15, 2023 in Amarillo, Texas.
Lindsay London holds a sign in support of access to abortion medication, outside the federal courthouse on Wednesday in Amarillo, Texas. David Erickson / AP file

More than half of women who terminate their pregnancies in the U.S. do so via medication abortion. If access to mifepristone is halted, those seeking an abortion, and their providers, would have to choose between a surgical procedure or taking the other medication in the regimen, misoprostol, off-label on its own.

The lawsuit, filed in November, alleges that the FDA did not adequately evaluate mifepristone’s safety before it approved the drug in 2000, and also argues the agency should not have made the medication accessible via telehealth during the pandemic. 

But the Biden administration argues the group doesn’t have the legal standing to bring the lawsuit. That’s one of the issues Kacsmaryk has told the lawyers to prepare to address in the hearing, along with the potential harm of halting access to mifepristone and the implications of implementing such an order nationwide. 

There is little legal precedent for a court to overturn a longstanding FDA approval, but abortion providers are nonetheless bracing for the possibility that Kacsmaryk — who was appointed by then-President Donald Trump — will grant the injunction request, since the judge has historically taken conservative stances on abortion rights and other issues.

Erik Baptist, senior counsel at Alliance Defending Freedom, the conservative Christian legal group representing the plaintiffs, said that “the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs.”

“We are not seeking a nationwide abortion ban — we’re focusing on one means of abortion here because it’s dangerous, and we are holding the FDA accountable for failing America’s women and girls,” Baptist added.

But the Biden administration has argued in court filings that the FDA reviewed the scientific evidence extensively before approving mifepristone, and that taking it off the market would cause worse health outcomes for people seeking abortions. 

The two-pill regimen has a 0.4% risk of major complications, research has shown.

“There’s never really been a case challenging the FDA approval of a drug in this way, when the science is so clear and it’s been on the market for so long and it’s so clearly safe,” said Cat Duffy, a policy analyst at the National Health Law Program, which works to protect abortion access.

Planned Parenthood and several abortion clinics said that if mifepristone gets pulled off the market, they would recommend that patients take misoprostol on its own, even though that approach may be less effective than the two pills together and more likely to cause uncomfortable side effects.

Kacsmaryk’s conservative record

Before becoming a judge, Kacsmaryk worked as deputy general counsel at the First Liberty Institute, a nonprofit Christian conservative legal organization. In 2015, he published articles criticizing abortion rights and same-sex marriage. 

Given that record, abortion rights advocates have accused the Alliance for Hippocratic Medicine of “forum shopping” — filing a lawsuit in a jurisdiction viewed as sympathetic to a cause. 

The group was registered in Amarillo in August 2022, three months after the Supreme Court overturned Roe v. Wade. Kacsmaryk is the only judge in the Amarillo Division of the Northern District of Texas and hears all civil cases there.

“In front of another judge, this case would have never seen the light of day and would have been dismissed on procedural grounds,” Duffy said.

How abortion providers plan to respond

Mifepristone blocks the hormone progesterone, while misoprostol induces contractions. The two-drug regimen is approved to terminate pregnancies up to 10 weeks. Patients typically take one mifepristone tablet, followed by four to eight tablets of misoprostol at least 24 to 48 hours later. 

“Medication abortion is incredibly safe. It’s safer than Tylenol,” said Amy Hagstrom Miller, the founder of Whole Woman’s Health, which operates abortion clinics in several states, including Maryland, Minnesota and Virginia. “What we’ve got here are people’s politics mixed up with science.”

Mifepristone and misoprostol pills  at a clinic for medication abortions.
Mifepristone and misoprostol pills at a clinic for medication abortions.Erin Hooley / Chicago Tribune via Getty Images file

Abortion providers said they worry about confusion and misinformation if the judge grants the injunction request, though their main concern is the potential effects on women’s health. On its own, Miller said, misoprostol is “not as comfortable for patients,” since they can experience more intense nausea, diarrhea, chills, vomiting or cramping as side effects.

Misoprostol may also be less effective when taken alone, which makes some abortion providers hesitant to rely on it.

“I would be reluctant to use off-label misoprostol a lot,” said Dr. Dmitriy Bronfman, medical director at the Brooklyn Abortion Clinic.

Studies have shown that misoprostol’s success rates generally range from 80% to 95%. Together, mifepristone and misoprostol can be up to 99.6% effective at terminating a pregnancy, according to a 2015 study.