A judge appointed by former President Donald Trump heard arguments on Wednesday in a lawsuit that aims to ban an abortion drug that has been widely used by women in the US for more than 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. His goal in filing the lawsuit was Overturn Food and Drug Administration approval about pills used to terminate pregnancy, which account for More than half of abortions in America
There was a request from the plaintiff on this issue for a preliminary injunction to pull mifepristone — one of the pills in the standard two-drug regimen — off the market nationwide as the case progresses.
Rowe v. Drugs used in medical abortion have become increasingly important in the fight for abortion rights since the overturning of Wade. Should Kacsmaryk order a ban on mifepristone, it would further hinder abortion access across the US
But at Wednesday’s hearing, lawyers for both sides focused largely on the FDA’s regulatory and approval process and did not mention abortion access or life-start.
Kacsmaryk appears to offer the plaintiff more window than the defense to clarify and elaborate its arguments, particularly those related to the FDA’s approval process and the scope of the potential injunction.
But the judge 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 shelves.
“No, I can’t,” replied Eric Baptiste, Senior counsel with the conservative Christian legal group Alliance Defending Freedom.
Why the legal challenge came so long after the drug’s approval, Baptiste blamed the FDA, saying the agency took 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.”
In response, 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.”
Jessica Ellsworth, who represents drug maker Danko Laboratories, said withdrawing approval for mifepristone would undermine both the public’s and the pharmaceutical industry’s trust in the FDA.
“This injunction is not about maintaining the status quo,” she said. “They want to maintain the status quo.”
Kacsmaryk commended both sides for presenting strong cases and said he would make a decision “as quickly as possible.”
Abortion clinics prepare to lose access to mifepristone
Wendy Davis, a senior advisor for Planned Parenthood Texas Votes, said that based on the judge’s background, the group is not optimistic.
“I think we can expect the worst, and I think we need to be prepared for that,” Davis said.
Before Trump selected Kaczmarik as a judge, she represented a conservative Christian group called the First Liberty Institute, which challenged the portion of the Affordable Care Act that required employers to cover birth control for their workers. was needed.
After a federal judge issued an injunction against that part of the law, Kaczmarić said it was a “important winas the group sought to “protect unborn human life”.
There was activity outside the court on Wednesday Abortion rights protesters and anti-abortion advocates who line up before sunrise to secure seats in the courtroom.
Among them was Nick Belcher of Amarillo and his 14-year-old daughter Julianne. Both said they expected the judge to rule in favor of banning the drug.
“I’m excited for this and the opportunities it presents to create a culture of life in America,” Belcher said.
had a hearing latest development In a lawsuit filed against the FDA in Nov.
In previous court filings and in its statements on Wednesday, the Biden administration argued that the Alliance for Hippocratic Medicine does not have legal standing to bring suit. It added 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.
Plaintiffs have argued that mifepristone is dangerous, that the FDA has not adequately evaluated its safety and that the agency should not have made abortion pills accessible via telehealth during the pandemic.
The FDA approved mifepristone in 2000. Abortion providers administer the drug — which blocks the hormone progesterone — in combination with misoprostol, which induces contractions.
research has shown That diet has a 0.4% risk of major complications.
Abortion providers said that if access to mifepristone was cut off, many clinics would administer misoprostol on their own off-label.
“People in the United States deserve access to the most accurate, effective medications, as proven by medical evidence, and mifepristone,” said Melissa Grant, chief operating officer of Carafem, an online abortion provider that delivers abortion pills through the mail. Certainly he is.” in 17 states. “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 according to a 2019 study, although it can cause more uncomfortable side effects, such as severe nausea, diarrhea, chills, vomiting, or cramps. drug is slightly less effective than a two-drug combo — its success rate usually range from 80% to 95%Compared to up to 99.6% to pair.
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in New York City, 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’m concerned, there is no safe place for women and girls in this country anymore.” “Maybe it will wake people up.”