In a case that seeks to outlaw an abortion drug that has been widely used by American women for more than 20 years, a judge appointed by former President Donald Trump heard arguments on Wednesday.
U.S. District Judge Matthew Kacsmaryk appeared receptive to the arguments made by the legal counsel for the Alliance for Hippocratic Medicine, a confederation of anti-abortion organizations, throughout the four-hour hearing. Their lawsuit sought to overturn the Food and Drug Administration’s approval of the pills used to end pregnancies, which are responsible for more than half of abortions in the United States.
The FDA’s Approval
At issue was a request from the plaintiffs for a preliminary injunction to pull mifepristone — one of the pills in the standard two-drug regimen — off the market nationwide while the case proceeds.
Since Roe v. Wade was overturned, the drugs used in medication abortions have taken on a greater significance in the debates over abortion rights. If Kacsmaryk were to impose a ban on mifepristone, it would make it harder for Americans to access abortions nationwide.
However, during the hearing on Wednesday, the attorneys for both sides largely concentrated on the FDA’s regulatory and approval process and neglected to bring up access to abortion or the beginning of life.
Kacsmaryk appeared to give the plaintiffs more opportunities than the defense to explain and bolster their claims, particularly those pertaining to the FDA’s approval procedure and the reach of a potential injunction.
When the judge questioned the attorneys for the Alliance for Hippocratic Medicine about another instance of a drug that had a long history of approval but was taken off the market, they were at a loss for words.
Erik Baptist, the senior counsel for the Alliance Defending Freedom, a conservative Christian legal organization, answered, “No, I can’t.
Baptist cited the FDA as the cause of the legal challenge’s tardiness, claiming that it took the agency 14 years to respond to a citizen petition expressing 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.”
Julie Straus Harris, a lawyer for the Justice Department, responded that it would be “unprecedented” to take away a medication that has been used safely for 20 years.
“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.”
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Jessica Ellsworth, who represents the pharmaceutical company Danco Laboratories, added that revoking approval for mifepristone would erode confidence in the FDA among both the general public and the pharmaceutical sector.
“This injunction is not about upholding the status quo,” she said. “They want very much to upend the status quo.”
Kacsmaryk praised both parties for making compelling arguments and promised to “make a decision as soon as possible.”
Abortion Clinics Prepare To Lose Access To Mifepristone
A senior adviser at Planned Parenthood Texas Votes, the organization isn’t hopeful given the judge’s past.
Before Trump chose Kacsmaryk to be a judge, he represented the First Liberty Institute, a conservative Christian organization, in a lawsuit against the Affordable Care Act’s requirement that employers provide birth control for their employees.
After a federal judge issued an injunction against that part of the law, Kacsmaryk said it was an “important victory” as the group sought to “defend unborn human life.”
A few abortion rights protesters and opponents of abortion lined up outside the courthouse on Wednesday morning to get seats in the courtroom.
Nic Belcher, an Amarillo resident, and Julianne, his 14-year-old daughter, were among them. Both parties expressed the hope that the judge would decide to outlaw the drug.
“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 in a November lawsuit against the FDA. The Biden administration argued in court filings and on Wednesday that the Alliance for Hippocratic Medicine lacks legal standing to sue. It stated that the FDA’s approval of mifepristone was supported by extensive scientific evidence and that withdrawing the drug would harm abortion patients’ health.
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The plaintiffs contend that mifepristone is dangerous, that the FDA did not adequately evaluate its safety, and that the agency should not have made abortion pills available via telehealth during the pandemic. Mifepristone was approved by the FDA in 2000.
Misoprostol, which causes contractions, and the drug, which blocks progesterone, are given together by abortionists. The regimen has a 0.4% risk of major complications. Abortion providers said that if mifepristone is unavailable, many clinics would use misoprostol 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, the 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, but it may cause more unpleasant side effects like severe nausea, diarrhea, chills, vomiting, or cramping. The medication is less effective than the two-drug combo, with success rates ranging from 80% to 95%.
Before the hearing, Merle Hoffman, founder, and CEO of Choices Women’s Medical Center in New York City, said the case shows that 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.”
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