A judge appointed by former President Donald Trump heard arguments on Wednesday in a lawsuit aimed at banning an abortion drug that has been widely used by American women for more than two decades.
During the four-hour hearing, U.S. District Judge Matthew Kaczmarik appeared to be sympathetic to the lawyers’ argument supporting the formation of a coalition of anti-abortion groups called the Hippocratic League of Medicine.The purpose of their lawsuit is Overturn FDA approval Pills used to terminate pregnancy accounted for More than half of all abortions in the U.S.
At issue is the plaintiff’s request preliminary injunction While the case was ongoing, mifepristone – one of the standard two-drug regimens – was withdrawn from the national market.
Since Roe v. Wade was overturned, the drug used in medical abortions has become increasingly important in the fight for abortion rights.If Kacsmaryk orders a ban on mifepristone, it will further hamper abortion across the U.S.
But at Wednesday’s hearing, lawyers for both sides focused on the FDA’s regulatory and approval process, and made no mention of abortion access or when life begins.
Kacsmaryk appears to have given plaintiffs more window than defense to clarify and elaborate their arguments, especially those related to FDA’s approval process and the scope of a potential injunction.
But when the judge asked lawyers for the Hippocratic League of Medicine if they could provide another example, they ran into a problem, a drug that had long been approved but was taken off the shelves.
“No, I can’t,” Erik Baptist replied, Senior advisor to the conservative Christian legal group Coalition for Freedom.
As for why the legal challenge took so long after the drug was approved, Baptist blamed the FDA, saying it took the agency 14 years to respond to petitions from citizens raising concerns about mifepristone.
“The court is interested in preventing dangerous drugs from entering the market,” Baptiste said. “Any relief you give must be complete. The dangers of chemical drugs are unlimited.”
In response, Justice Department attorney Julie Straus Harris said it would be “unprecedented” to cancel a drug that has been used safely for 20 years.
“It’s important to step back and think about what the agency is doing here,” Harris said. “The FDA isn’t asking anyone to take it—they’re just saying it’s safe and effective.”
Jessica Ellsworth, who represents drugmaker Danco Laboratories, added that revoking the approval of mifepristone would undermine public and pharmaceutical industry trust in the FDA.
“This ban is not about maintaining the status quo,” she said. “They very much want to upend the status quo.”
Kacsmaryk praised both sides for making strong cases and said he would “make a decision as soon as possible.
Abortion Clinics Prepare to Lose Mifepristone
Wendy Davis, a senior counsel with Planned Parenthood Texas Votes, said the group isn’t optimistic based on the judge’s background.
“I think we can expect the worst and I think we need to be prepared for that,” Davis said.
Before Trump chose Kacsmaryk to serve on the bench, he represented a conservative Christian group called the First Liberty Institute, which challenged the portion of the Affordable Care Act that required employers to pay for birth control for employees.
After a federal judge issued an injunction against that part of the law, Kacsmaryk said it was “major victoryas the group seeks to “defend unborn human life.”
Wednesday was sporadic outside the courthouse Abortion rights demonstrators and anti-abortion advocates line up before sunrise to secure seats in court.
Among them were Nick Belcher of Amarillo and his 14-year-old daughter Julianne. Both said they wanted the judge to rule in favor of banning the drug.
“I’m excited about this and the opportunity to create a culture of living in America,” Belcher said.
the hearing is Latest News in a lawsuit filed against the FDA in November.
In previous court filings and Wednesday’s statement, the Biden administration argued that the Hippocrates Medical Union did not have the legal standing to bring the lawsuit. It said the FDA’s approval of mifepristone was supported by extensive scientific evidence and that taking the drug off the market would lead to worse health outcomes for people seeking abortions.
The plaintiffs argue that mifepristone is dangerous, that the FDA has not adequately assessed its safety, and that the agency should not be offering abortion pills via telemedicine during the pandemic.
The FDA approved mifepristone in 2000. Abortion providers combine this drug with misoprostol, which blocks the hormone progesterone, which causes contractions.
research shows This regimen had a 0.4% risk of major complications.
Abortion providers say many clinics will use misoprostol off-label on their own if mifepristone supplies are cut off.
“Americans deserve the most accurate, most effective medicines that the medical evidence has proven, and mifepristone absolutely does,” said Melissa Grant, chief operating officer of Carafem, an online abortion provider that delivers abortion pills by mail. in 17 states. “Mifepristone and misoprostol complement each other well and are the best and most effective way to terminate an early pregnancy medically.”
Misoprostol is safe when taken alone, according to an expert Study in 2019, although it may cause more uncomfortable side effects such as intense nausea, diarrhea, chills, vomiting or cramping.The drug was slightly less effective than the combination of the two drugs – its Success rate Generally speaking Range from 80% to 95%compared to Up to 99.6% For this pair.
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in New York City, said before the hearing that the case showed that even state-level protections are not enough to guarantee abortion.
“Everyone is saying, ‘Well, New York is safe.’ As far as I’m concerned, there’s no safe place for women and girls in this country anymore,” she said. “Maybe this will wake people up.”