AMARILLO, Texas — A judge appointed by former President Donald Trump heard arguments Wednesday in a lawsuit that aims to ban an abortion medication that has been widely used by millions of American women for over two decades.
During the four-hour hearing, U.S. District Judge Matthew Kacsmaryk appeared sympathetic to arguments from the lawyers for a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine. Their goal in filing the suit was to overturn the Food and Drug Administration’s approval of the pills used to terminate pregnancies, which account for more than half of abortions in the U.S.
At issue was a request from the plaintiffs for the judge to grant a preliminary injunction against mifepristone — one pill in the two-drug regimen — taking it off the market nationwide while the case proceeds.
But Kacsmaryk stumped the Alliance for Hippocratic Medicine’s lawyers when he asked if they could offer another example of a drug with a long-established approval that was yanked from clinic or hospital shelves.
“No, I can’t,” replied Erik Baptist, senior counsel with the conservative Christian legal group Alliance Defending Freedom.
As to the reason 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 citizens’ petition raising concerns about mifepristone.
“The court has an interest in preventing dangerous drugs from entering the marketplace,” Baptist said. “Any relief you grant must be complete. The harm of chemical drugs knows no bound.”
However, Justice Department lawyer Julie Straus Harris said removing a drug that has been used safely for 20 years would be “unprecedented.”
“It is important to step back and think about what the agency did here,” Harris said. “The FDA did not require anyone to take it — they simply said it is safe and effective.”
Kacsmaryk said he would “make a decision as soon as possible.”
Outside the courthouse was a smattering of demonstrators both for and against abortion rights.
Nic Belcher, of Amarillo, was part of a small group of demonstrators who want the drug banned. He brought along his 14-year-old daughter, Julianne.
“I’m excited for 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 prior court filings and its arguments on Wednesday, the Biden administration argued that the Alliance for Hippocratic Medicine doesn’t 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 did not adequately evaluate the drug’s safety before approving it, and that the agency should not have made abortion pills accessible via telehealth during the pandemic.
The FDA approved mifepristone in 2000. Abortion providers currently 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 they are prepared for access to mifepristone to be cut off, in which case many clinics would start to administer misoprostol on its own off-label.
“People in the United States deserve to have the most accurate, effective medications as proven by medical evidence, and mifepristone is definitely that,” said Melissa Grant, chief operating officer of Carafem, an online abortion provider that sends abortion pills through the mail in 17 states. “Together, mifepristone and misoprostol complement each other extraordinarily well and are the best and most effective way to end an early pregnancy with medication.”
Misoprostol is safe to take on its own, with a 0.7% risk of major complications, according to a 2019 study, though it could cause more uncomfortable side effects, such as intense nausea, diarrhea, chills, vomiting or cramping. The medication is slightly less effective than the two-drug combo — its success rates generally range from 80% to 95%, compared to up to 99.6% for the pair.
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in Queens, said ahead of the hearing that the case suggests even state-level protections aren’t enough to guarantee abortion access.
“Everybody was saying, ‘Well, New York is safe.’ And as far as I’m concerned, there’s no safe place anymore 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.