AMARILLO, Texas — A judge appointed by former President Donald Trump heard arguments Wednesday in a lawsuit seeking to ban an abortion drug that has been widely used by American women for more than two decades.
During the four-hour hearing, US District Judge Matthew Kacsmaryk was sympathetic to the arguments of lawyers for a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine. His goal in filing the lawsuit was to void the Food and Drug Administration’s approval of pills used to terminate pregnancies, which represent more than half of abortions in the US
At issue was a request by the plaintiffs for a preliminary injunction to withdraw mifepristone, a pill in the standard two-drug regimen, from the market nationwide while the case progresses.
The drugs used in medical abortions have become increasingly important in abortion rights fights since Roe v. Wade. If Kacsmaryk were to order a ban on mifepristone, that would further restrict abortion access in the US. But at Wednesday’s hearing, lawyers for both sides focused heavily on the FDA approval and regulatory process. and they did not mention access to abortion or when life begins.
Kacsmaryk stumped lawyers for the Alliance for Hippocratic Medicine when he asked if they could offer another example of a drug with long-standing approval being pulled from shelves.
«No, I can’t,» replied Erik Bautista, Senior counsel for the conservative Christian legal group Alliance Defending Freedom.
As for why this legal challenge came so long after the drug’s approval, Baptist blamed the FDA, saying it took the agency 14 years to respond to a petition from citizens raising concerns about mifepristone.
«The court has an interest in preventing dangerous drugs from entering the market,» Baptist said. “Any relief you grant must be complete. The harm of chemical drugs knows no bounds.»
In response, Justice Department attorney Julie Straus Harris said removing a drug that has been used safely for 20 years would be «unprecedented.»
«It’s important to step back and think about what the agency did here,» Harris said. «The FDA didn’t require anyone to take it, they just said it’s safe and effective.»
Jessica Ellsworth, who represents the pharmaceutical company Danco Laboratories, added that withdrawing the approval of mifepristone would undermine the confidence of the public and the pharmaceutical industry in the FDA.
«This injunction is not about maintaining the status quo,» he said. «They want very much to change the status quo.»
Kacsmaryk said he would «make a decision as soon as possible» and complimented both sides for presenting strong cases.
Abortion clinics prepare to lose access to mifepristone
Wendy Davis, senior counsel for Planned Parenthood Texas Votes, said that based on cross-examination by the judge, the group is not optimistic.
“I think we can expect the worst and I think we have to be prepared for that,” Davis said.
Before Trump chose Kacsmaryk to be a judge, he represented a conservative Christian group called the First Liberty Institute, which challenged the part of the Affordable Care Act that required employers to cover birth control for their workers. .
After a federal judge issued an injunction against that part of the law, Kacsmaryk said it was a «important victoryas the group sought to «defend unborn human life.»
Outside the courthouse on Wednesday were a handful of Abortion rights protesters and anti-abortion advocates who lined up before dawn to secure seats inside the courtroom.
Among them was Nic Belcher, of Amarillo, and his 14-year-old daughter, Julianne. Both said they hoped the judge would rule in favor of banning the drug.
“I’m excited about this and the opportunities that exist to create a culture of life in America,” Belcher said.
The hearing was the latest development in a lawsuit filed against the FDA in November.
In previous court filings and its depositions on Wednesday, the Biden administration argued that the Alliance for Hippocratic Medicine does not have the legal standing to bring the lawsuit. They also said the FDA’s approval of mifepristone was supported by extensive scientific evidence, and that taking the drug off the market would cause worse health outcomes for people seeking abortions.
The plaintiffs have argued that mifepristone is dangerous, that the FDA failed to adequately evaluate the drug’s safety, and that the agency should not have made abortion pills accessible via telehealth during the pandemic.
The FDA approved mifepristone in 2000. Currently, abortion providers administer the drug, which blocks the hormone progesterone, in combination with misoprostol, which induces contractions.
Research has shown that the regimen has a 0.4% risk of major complications.
Abortion providers said that if access to mifepristone is cut off, many clinics would start administering misoprostol on its own label.
«People in the United States deserve to have the most accurate and effective medications, as shown by medical evidence, and mifepristone is definitely that,» said Melissa Grant, chief operating officer of Carafem, an online abortion provider that mail abortion pills at 17. «Together, mifepristone and misoprostol complement each other remarkably well and are the best and most effective way to end an early pregnancy with medication.»
Misoprostol is safe to take alone, with a 0.7% risk of serious complications, according to a study 2019, although it could cause more uncomfortable side effects, such as severe nausea, diarrhea, chills, vomiting, or cramps. The drug is slightly less effective than the combination of two drugs: its success rates generally range from 80% to 95%in comparison with up to 99.6% for the couple
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in Queens, said before the hearing that the case suggests that even protections at the state level are not enough to guarantee access to abortion.
“Everybody was like, ‘Well, New York is safe.’ And as far as I’m concerned, there is no longer a safe place for women and girls in this country,” she said. «Maybe this will wake people up.»
Alicia Victoria Lozano and Dasha Burns reported from Amarillo, and Corky Siemaszko and Aria Bendix from New York City.