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 suit, called the Alliance for Hippocratic Medicine, requested a preliminary injunction to withdraw one of the two drugs, mifepristone, from the national market while the case progresses.
That request is the focus of Wednesday’s hearing, scheduled for 9 am local time, though it is not known when US District Judge Matthew Kacsmaryk will issue his decision; It could be on Wednesday or in the following days or weeks.
More than half of the women Those who terminate their pregnancies in the US do so through medical abortion. If access to mifepristone is stopped, abortion seekers and their providers would have to choose between a surgical procedure or taking the other drug in the regimen, misoprostol, on its own.
The lawsuit, filed in November, alleges that the FDA failed to adequately evaluate the safety of mifepristone before approving the drug in 2000, and also argues that the agency should not have made the drug accessible via telehealth during the pandemic.
But the Biden administration argues that the group does not have the legal standing to bring the lawsuit. That’s one of the issues Kacsmaryk has told lawyers to prepare to address at the hearing, along with the potential harm of stopping access to mifepristone and the implications of implementing such an order across the country.
There is little legal precedent for a court to overturn a longstanding FDA approval, but abortion providers are bracing for the possibility that Kacsmaryk, who was appointed by then-President Donald Trump, will grant the request for action. precautionary, since the judge has historically made conservative decisions. positions on the right to abortion and other issues.
Erik Baptist, lead attorney for 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 looking for a nationwide abortion ban; we’re targeting a means of 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 documents that the FDA thoroughly 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 major complications, Research has shown.
«There’s really never been a case that challenges 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. of the National Health Law Program, which works to protect access to abortion.
Planned Parenthood and several abortion clinics said that if mifepristone were to be withdrawn from the market, they would recommend that patients take misoprostol alone, although 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 a deputy general counsel at the First Liberty Institute, a non-profit Christian conservative legal organization. In 2015, he published articles criticizing the right to abortion and same-sex marriage.
Given that record, abortion rights advocates have accused the Alliance for Hippocratic Medicine of “forum buying”—filing a lawsuit in a jurisdiction deemed favorable to a cause.
The group registered in Amarillo in August 2022, three months after the Supreme Court struck down Roe v. Wade. Kacsmaryk is the only judge for the Amarillo Division of the Northern District of Texas and hears all civil cases there.
«In front of 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 induces contractions. The two-drug regimen is approved to terminate pregnancies up to 10 weeks. Patients usually take one mifepristone tablet, followed by four to eight misoprostol tablets at least 24 to 48 hours later.
“Medication abortion is incredibly safe. It’s safer than Tylenol,” said Amy Hagstrom Miller, founder of Whole Woman’s Health, which operates abortion clinics in several states, including Maryland, Minnesota and Virginia. «What we have here is popular politics mixed with science.»
Abortion providers said they are concerned about confusion and misinformation if the judge grants the court order, though their main concern is the potential effects on women’s health. By itself, Miller said, misoprostol «is not as comfortable for patients,» as they may experience nausea, diarrhea, chills, vomiting or more severe cramping as side effects.
Misoprostol may also be less effective when taken alone, making some abortion providers hesitant to trust it.
“I would be reluctant to use a lot of off-label misoprostol,” said Dr. Dmitriy Bronfman, medical director of 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 in terminating a pregnancy. according to a 2015 study.