by AMARILLO, Texas — A judge appointed by former President Donald Trump on Wednesday heard arguments in a lawsuit aimed at banning an abortion drug that has been widely used by millions of American women for over two decades.
During the four-hour hearing, US District Judge Matthew Kacsmaryk agreed with the arguments put forward by attorneys for a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine. Her 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 abortions in the United States
It concerned a plaintiffs request for the judge to issue an injunction against mifepristone — a pill in two-drug therapy — to take it off the market nationwide while the case proceeds.
But Kacsmaryk surprised lawyers at the Alliance for Hippocratic Medicine when he asked if they could offer another example of a drug with a long-standing approval that has been ripped off clinic or hospital shelves.
“No, I can’t,” replied Erik Baptist, Senior Counsel of the conservative Christian rights group Alliance Defending Freedom.
As to 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 citizen petition 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.”
But Justice Department attorney Julie Straus Harris said the removal of a drug that has been safely used for 20 years is “unprecedented”.
“It’s important to take a step back and reflect on what the agency has done 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”.
Outside the courthouse were a few pro and anti abortion protesters.
Nic Belcher, from Amarillo, was part of a small group of protesters who want the drug banned. He brought his 14-year-old daughter Julianne with him.
“I’m very 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 earlier court filings and their arguments Wednesday, the Biden administration argued that the Alliance for Hippocratic Medicine lacked legal authority to bring the lawsuit. They 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 outcomes for people who want an abortion.
Plaintiffs have argued that mifepristone is dangerous, that the FDA did not adequately assess the drug’s safety before approval, and that the agency should not have made abortion pills available via telemedicine 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 triggers contractions.
Research has shown that the regimen carries a 0.4% risk of serious complications.
Abortion providers said they were prepared for access to mifepristone to be shut down. In this case, many clinics would start administering misoprostol on their own.
“People in the United States deserve to have the most accurate and effective medications backed by medical evidence, and mifepristone definitely is,” said Melissa Grant, chief operating officer of Carafem, an online abortion provider that sells abortion pills per Mail sent 17. “Together, mifepristone and misoprostol complement each other extremely well and are the best and most effective way to terminate an early pregnancy with drugs.”
Misoprostol is safe to take alone, according to a 2019 study, with a 0.7% risk of serious complications, although it could cause more uncomfortable side effects like severe nausea, diarrhea, chills, vomiting, or convulsions. The drug is slightly less effective than the two-drug combination — its success rates are generally between 80% and 95%, compared to 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 even state-level protections are insufficient to guarantee access to abortion.
“Everyone said, ‘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 that will wake people up.”
Alicia Victoria Lozano and Dasha Burns reported from Amarillo, Corky Siemaszko and Aria Bendix from New York City.
