AMARILLO, Texas – A judge appointed by former President Donald Trump heard arguments Wednesday in a lawsuit that aims to ban an abortion drug widely used by millions of American women for two decades.
During the four-hour hearing, US District Judge Matthew Kaczmarik appeared sympathetic to the arguments of lawyers for a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine. Their goal in filing the lawsuit was to overturn the Food and Drug Administration’s approval of the pills used to terminate pregnancies, which account for more than half of all abortions in the US.
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 progresses.
But Kacsmaryk stumped lawyers for the Alliance for Hippocratic Medicine when they asked if they could offer another example of a drug with long-established approval that had been pulled from clinic or hospital shelves.
“No, I can’t,” replied Eric Baptiste, Senior counsel with the conservative Christian legal group Alliance Defending Freedom.
As to why this legal challenge came so long after the drug’s approval, Baptiste 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,” Baptiste said. “Any relief you provide must be absolute. There is no limit to the harm of chemical drugs.”
However, Justice Department attorney Julie Strauss Harris said it would be “unprecedented” to remove a drug that has been used safely for over 20 years.
“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 was safe and effective.”
Kacsmaryk said he would make a decision “as soon as possible.”
There were a large number of protesters for and against abortion rights outside the courthouse.
Nick Belcher, of Amarillo, was part of a small group of protesters who want the drug banned. He brought his 14-year-old daughter Julianne along.
“I’m excited for this and the opportunities it presents 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 does not have legal standing to bring suit. He also said that the FDA’s approval of mifepristone was supported by extensive scientific evidence, and that removing the drug from the market would result in worse health consequences 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 anorexia has a 0.4% risk of major complications.
Abortion providers said they are prepared to cut off access to mifepristone, in which case many clinics would begin administering misoprostol on their own off-label.
“People in the United States should have access to the most accurate, effective medicines, as proven by medical evidence, and mifepristone is certainly that,” said Melissa Grant, chief operating officer of Carafem, an online abortion provider that Sends abortion pills through the mail. 17 says. “Together, mifepristone and misoprostol complement each other exceptionally 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, although it can cause more uncomfortable side effects, such as intense nausea, diarrhea, chills, vomiting, or cramps. The drug is slightly less effective than the two-drug combo—its success rate typically ranges from 80% to 95%, compared to 99.6% for the pair.
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in Queens, said before the hearing that the case shows that even state-level protections are not enough to guarantee abortion access.
“Everybody was saying, ‘Well, New York is safe.’ And as far as I am concerned, there is no safe place for women and girls in this country anymore. “Maybe it will wake people up.”
Alicia Victoria Lozano and Dasha Burns reported from Amarillo, and Corky Simazko and Aria Bendix from New York City.
