A Texas court heard a closely watched case on Wednesday on the future of a key abortion medication amid protests against the presiding judge’s decision not to publicize the hearing.
Justice department officials, drug company attorneys and lawyers from the anti-abortion Alliance Defending Freedom gathered in the remote city of Amarillo, Texas, for a hearing before Judge Matthew Kacsmaryk with the district court for the northern district of Texas. Kacsmaryk was asked by anti-abortion groups to grant a preliminary injunction revoking the Food and Drug Administration’s approval of mifepristone, one of two medications used in more than 50% of all abortions in the US.
A decision overturning approval of the drug would apply nationwide, not only in the states that have banned or restricted abortion.
In a hearing that lasted more than four hours, the judge asked both sides questions about the administrative law governing the FDA and whether the plaintiffs had standing to bring the case. Appearing to take pains to seem neutral, he gave little inclination of how he would rule, but promised a decision would come “as soon as possible”. He offered nothing beyond that in terms of a timeline.
Attorney Erik Baptist, arguing for the Alliance Defending Freedom, said “any relief must be complete, universal and nationwide” as “the harms of chemical abortion drugs know no bounds”. Medication abortion has been repeatedly found to be extremely safe.
“Any injunction would cause significant harm by depriving patients of a drug that has been on the market for two decades,” said Julie Straus Harris, arguing for the Department of Justice.
One of the alliance’s chief arguments against the FDA is that it misused its authorities when it originally approved the pill.
The FDA reviewed the drug under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it has been used to expedite drugs for cancer and other “serious or life-threatening diseases”.
The alliance, which was also involved in the lawsuit that led the supreme court to overturn Roe v Wade, argues that pregnancy is not a disease and therefore mifepristone should not have been considered for accelerated approval.
“The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be more stark,” Baptist told Kacsmaryk.
But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, while the FDA reviewed the drug under its accelerated approval regime, it did not expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone, including requiring physicians to be certified before prescribing it.
Lawyers for the plaintiffs argued that they have standing to sue because the physicians they represent had to treat women dying or very ill from “failed chemical abortions”.
“The FDA’s unlawful actions have harmed women and girls for far too long,” the alliance concluded.
Attorneys for the government said that adverse effects requiring medical intervention are exceedingly rare, and that the statute of limitations for challenging the approval of the drug had long run out.
Outside, Women’s March organizers held a “kangaroo court” protest, with demonstrators dressed as judges and kangaroos in reference to Kacsmaryk’s attempt to keep the hearing secret by not publicizing it in advance on the court’s docket. Anonymous sources leaked the news to the Washington Post and it was eventually formally announced on Monday evening. A decision could come as soon as Wednesday.
Dozens of people were in line by 6am CT in order to enter the northern Texas court for the hearing, which was scheduled to begin at 9am.
That delay in public notice “really has had a chilling effect on our ability to exercise our right to peaceful protest”, said Rachel O’Leary Carmona, executive director of the Women’s March.
Women’s March organizers planned to hold a mock trial outside the courthouse, reading aloud statements that the Trump-appointed judge has previously made about women, immigration and abortion. “We’re going to make sure that folks understand exactly what kind of person is running this kangaroo court inside and the ways in which he has actually made very clear that he is not an impartial jurist, but in fact, a politician who is trying to legislate from the bench,” she said.
This was the first hearing in the case, Alliance for Hippocratic Medicine v US Food and Drug Administration. Any decision would probably be appealed to the conservative US court of appeals for the fifth circuit, and possibly to the supreme court.
If Kacsmaryk overturns the FDA approval of mifepristone, it is unclear how access to the drug would be affected in the short term, and some legal experts argue that the agency would not be required to enforce the decision. Some abortion providers have said they would continue to prescribe misoprostol, the other drug used in the two-step protocol, which has been found to be effective on its own in ending pregnancies, although at a slightly lower rate than when used in conjunction with mifepristone.
Mifepristone has been available in the US since 2000 and internationally since 1988. While it has been found to be safer than Tylenol or Viagra, it is regulated more strictly than fentanyl. The anti-abortion groups hope that Kacsmaryk’s conservative history is an indication he will rule in their favor.
Although the Alliance for Hippocratic Medicine has a Tennessee mailing address, it incorporated in Amarillo in August 2022 before filing suit against the FDA in November – thereby ensuring the case would be heard by Kacsmaryk, who has called gay people “disordered” and claimed that being transgender is a “mental disorder”. He has ruled against Biden administration guidelines banning discrimination against transgender people. Another one of his decisions requires minors to obtain parental consent before acquiring birth control.
In a Friday call with attorneys representing the Alliance, the FDA and the drug company Danco, which manufactures mifepristone, Kacsmaryk asked “the parties avoid further publicizing the date of the hearing”, citing death threats to court staff. The scheduling of that call was not published on the court’s official docket until after the fact, and Kacsmaryk advised the attorneys that he would not publish notice of Wednesday’s hearing until “after business hours” on Tuesday.
After anonymous sources leaked news of the hearing to the Washington Post, five media companies and three press freedom groups sent a letter to Kacsmaryk, urging him to “immediately docket notice of the hearing” to allow press adequate time to travel to the remote courthouse, and calling his attempt to limit attendance at the hearing “unconstitutional”. The court’s website was updated with notice of the 9am hearing on Monday evening.
Women’s March organizers planned a second protest for Wednesday evening, with demonstrators encouraged to come dressed as clowns – in reference to a comment by Kacsmaryk on the Friday call, when he asked attorneys them not to share details of the hearing so “we don’t have any unnecessary circus-like atmosphere”.
The Associated Press contributed to this report
