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Was the FDA wrong to approve a drug that’s used in nearly all medication abortions in the U.S. — and should the drug, mifepristone, be taken off the market? Those questions were argued in court Wednesday, in a case heard by controversial federal Judge Matthew Kacsmaryk in Amarillo, Texas.
If the lawsuit succeeds, it could have sweeping repercussions — for abortion providers and patients across the nation, as well as for the FDA’s drug-approval process. At least 25 states have filed amicus briefs in the case.
A coalition of anti-abortion medical groups and doctors called the Alliance for Hippocratic Medicine sued the FDA back in November, saying the abortion pill mifepristone was improperly approved two decades ago as part of a two-drug protocol that’s used to end pregnancies in the first trimester.
Attorneys from the Justice Department argued on behalf of the FDA at Wednesday’s hearing, as did lawyers for the drug company Danco, which makes mifepristone.
Kacsmaryk could now decide the case at any time. Here’s a guide to what’s at stake in the lawsuit:
What happened on Wednesday?
The plaintiffs have filed a motion seeking a preliminary injunction to remove mifepristone from the U.S. market or limit its availability. The FDA has asked the judge to deny that motion, saying the lawsuit isn’t likely to succeed. In court filings, the agency also said that while injunctions are commonly issued to preserve the status quo, in this case, an injunction “would upend the status quo” that has held for more than 20 years.
Wednesday’s proceeding was a hearing on the injunction motion, with each side given two hours to present their arguments.
Mifepristone has been used by about 5 million people since it was approved in 2000, and major medical groups say it has a very strong safety record. It induces what is essentially a miscarriage, and there can be complications.
Erin Hawley, an attorney representing Alliance for Hippocratic Medicine, argued that doctors who are part of this group have been forced to treat patients who have experienced complications, which can include heavy bleeding. In some cases, Hawley said, doctors have been forced to provide a surgical procedure to complete the abortion, despite their deeply held beliefs.
A lawyer for Danco responded that “all drugs have side effects” and suggested that treating those patients is a normal part of being a doctor.
Attorneys argued over mifepristone’s original approval
The FDA says it approved the drug after “a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.”
Lawyers for the Alliance for Hippocratic Medicine argued that the FDA’s approval relied on an obscure regulation for drugs used to treat serious illnesses.
“Pregnancy is not an illness,” attorney Erik Baptist said as he argued that mifepristone was improperly approved.
Lawyers defending the FDA countered that pregnancy can be life threatening for some patients, and they said regardless of whether pregnancy is described as an illness or a condition, the wording is irrelevant in terms of whether the drug is safe.
Justice Department lawyer Julie Straus Harris pointed out that mifepristone has been used in the U.S. for decades and that taking it off the market would cause harm to patients who rely on this drug.
Judge Kacsmaryk asked Straus Harris what she made of the fact that Republican attorneys general from more than 20 states — states that have tried to restrict abortion following last summer’s Supreme Court decision overturning Roe v. Wade — filed a brief in the case saying that the wide availability of abortion pills undermines those state restrictions.
Straus Harris responded that this argument is beside the point. She said the FDA approval simply confirmed the drug’s safety and effectiveness and doesn’t require anyone to prescribe it or take it.
“The plaintiffs are the ones who are trying to dictate national policy” with this lawsuit, she said.
What could the judge do?
Kacsmaryk has a number of options, from leaving the drug on the market to restoring rules around mifepristone that the FDA and the Biden administration have eased. Recent changes include allowing mifepristone to be mailed or dispensed by retail pharmacies. And in 2016, the agency decided to allow mifepristone to be used during the first 10 weeks of pregnancy, up from seven weeks.
During the hearing, Kacsmaryk appeared to be considering whether he should order the drug to be taken off the market right away or order the FDA to take some other action.
Alliance lawyers are urging the judge to grant a nationwide injunction that would take effect immediately and would at least temporarily remove the drug from the market while this case plays out.
Lawyers for the FDA asked the judge that, should he side with the plaintiffs, any decision focus on addressing specific issues, rather than curtailing all access to mifepristone.
Whatever Kacsmaryk decides, it will likely be appealed and could eventually end up before the Supreme Court.
Who is the judge?
Kacsmaryk was appointed in 2019 by then-President Trump. He has longstanding ties to conservative religious groups, and his critics accused the group behind this lawsuit of judge shopping — filing their case in a venue they view as friendly to far-right views.
“It’s no accident that the complaint was filed in Amarillo,” Elizabeth Sepper, a University of Texas at Austin law professor, previously told NPR, adding that the plaintiffs “know they have a very sympathetic ear” in Kacsmaryk.
Because of the way the federal courts work here, Sepper said, it was a virtual certainty that Kacsmaryk would be assigned to the case.
The judge made news in December when he ruled in favor of a man who filed suit trying to stop federal family planning clinics in Texas from dispensing contraception to minors without their parent’s permission. He said he was a Christian, and the possibility that a clinic would give birth control to his teenage daughters violated his religious beliefs. Kacsmaryk agreed.
Public access to the hearing is limited
Only a small group of reporters and members of the public, some of whom waited in line starting as early as 5 a.m., were allowed into the courtroom for Wednesday’s proceedings. The small Amarillo courtroom offers seats for just a few dozen people.
The hearing was livestreamed in another federal courtroom, in Dallas, but no recordings were allowed.
Even before Wednesday’s hearing, there were clashes over public and press access to the Amarillo courthouse.
A coalition of media groups filed an objection on Monday after The Washington Post reported that Kacsmaryk sought to delay public notice of the hearing date from appearing in the court docket until late Tuesday, in an apparent bid to limit protests and press at the courthouse. The judge also reportedly told lawyers in the case not to share details about the hearing.
Such a delay violates the First Amendment, the media outlets said in their court filing, adding that it harms people across the ideological spectrum who are interested in the case.
“The Court cannot constitutionally close the courtroom indirectly when it cannot constitutionally close the courtroom directly,” the objection stated.
Shortly after that filing, Kacsmaryk ordered notice of the hearing to be posted to the court’s public docket.