A federal judge in Texas will hold a hearing Wednesday in a lawsuit seeking to overturn the Food and Drug Administration’s approval of pills used in medical abortions.
The coalition of anti-abortion groups behind the lawsuit, called the Alliance for Hippocratic Medicine, has asked for 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, scheduled for 9 a.m. local time, though it’s not known when U.S. District Judge Matthew Kaczmaric will issue his ruling — it could be Wednesday or later days or weeks.
More than half of women who terminate their pregnancies in the US do so through medical abortion. If access to mifepristone is cut off, abortion seekers and their providers will have to choose between surgery or taking the other drug in the regimen, misoprostol, off-label by itself.
The lawsuit, filed in November, alleges that the FDA did not adequately evaluate the safety of mifepristone before approving the drug in 2000, and also argues that the agency should not have made the drug available via telehealth during the pandemic.
But the Biden administration argues the group lacks legal standing to sue. That’s one of the issues Kacsmaryk told lawyers to prepare to address at the hearing, along with the potential harm of cutting off access to mifepristone and the ramifications of implementing such a mandate 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, as the judge had historically conservative positions on abortion rights and other issues.
Erik Baptist, senior counsel for the Alliance Defending Freedom, the conservative Christian legal group representing the plaintiffs, said “the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs.”
“We’re not seeking a nationwide ban on abortion — we’re focusing on an abortion here because it’s dangerous and we’re 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 extensively reviewed the scientific evidence before approving mifepristone and that removing it from the market would cause worse health outcomes for people seeking abortions.
The two-pill regimen has a 0.4% risk of serious complications, research has shown.
“There’s never really been a case of challenging the FDA’s 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 National. Program on the Health Act, which works to protect access to abortion.
Planned Parenthood and several abortion clinics have said that if mifepristone is pulled from the market, they would recommend that patients take misoprostol alone, even though that approach may be less effective than the two pills together and more likely to cause unpleasant 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 suit in a jurisdiction deemed sympathetic to a cause.
The group registered in Amarillo in August 2022, three months after the Supreme Court overturned Roe v. Wade. Kacsmaryk is the sole judge in the Amarillo Division of the Northern District of Texas and hears all civil cases there.
“Before another judge, this case would never have seen the light of day and would have been thrown out on procedural grounds,” Duffy said.
How abortion providers plan to respond
Mifepristone blocks the hormone progesterone, while misoprostol causes contractions. The two-drug regimen is approved for termination of pregnancy up to 10 weeks. Patients usually take one mifepristone tablet, followed by four to eight misoprostol tablets at least 24 to 48 hours later.
“Medicated 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 have here is the politics of people mixed with science.”
Abortion providers said they worry about confusion and misinformation if the judge grants the injunction request, though their main concern is the potential impact on women’s health. By itself, Miller said, misoprostol “isn’t as comfortable for patients,” as they may experience more severe nausea, diarrhea, chills, vomiting or cramps as side effects.
Misoprostol may also be less effective when taken alone, which makes some abortion providers reluctant to rely on it.
“I would be reluctant to use much off-label misoprostol,” said Dr. Dmitri Bronfman, medical director at the Brooklyn Abortion Clinic.
Studies have shown that the success rates of misoprostol 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.