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In abortion pill case, Texas judge plans to suspend access to mifepristone


A Texas federal judge will hold a hearing Wednesday in a lawsuit seeking to overturn the Food and Drug Administration’s approval of pills used in medical abortions.

The coalition of anti-abortion groups behind the lawsuit, called the Hippocratic Medicine Alliance, has sought a preliminary injunction to remove one of the two drugs, mifepristone, from the national market while the case progresses. .

That request is the focus of Wednesday’s hearing, scheduled for 9 a.m. local time, though it’s unclear when U.S. District Judge Matthew Kacsmaryk will deliver his ruling — it could come Wednesday or later. or following weeks.

More than half of women who terminate their pregnancies in the United States do so via medical abortion. If access to mifepristone is cut off, those seeking an abortion and their providers will have to choose between surgery or taking the regimen’s other drug, off-label misoprostol, alone.

The lawsuit, filed in November, alleges that the FDA failed to adequately assess the safety of mifepristone before approving the drug in 2000, and also argues that the agency should not have made the drug available through telehealth during the pandemic.

But the Biden administration argues the group lacks the legal status to sue. This is one of the issues Kacsmaryk told lawyers to be prepared to address in court, along with the potential harm of stopping access to mifepristone and the implications of implementing such an order nationwide.

There are few legal precedents for a court to overturn a longstanding FDA approval, but abortion providers are nonetheless bracing for the possibility that Kacsmaryk – who was appointed by then-President Donald Trump – grants the request for an injunction, since the judge has always made conservative decisions. positions on abortion rights and other issues.

Erik Baptist, senior counsel at Alliance Defending Freedom, the conservative Christian legal group representing the plaintiffs, said “the purpose of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs.”

“We are not seeking to ban abortion nationwide – we are focusing here on a means of abortion because it is dangerous, and we hold the FDA accountable for the failure of American women and girls” , added Baptist.

But the Biden administration has argued in court filings that the FDA thoroughly reviewed the scientific evidence before approving mifepristone, and that removing it from the market would lead to worse health outcomes for people seeking abortions.

The two-pill diet has a 0.4% risk of major complications, according to research.

“There’s never really been a case challenging FDA approval of a drug in this way, when the science is so clear and it’s been on the market for so long and it’s so clearly safe,” said Cat Duffy, a policy analyst at the National Health Law Program, which works to protect access to abortion.

Planned Parenthood and several abortion clinics have said that if mifepristone is taken off the market, they would recommend patients take misoprostol alone, even though this approach may be less effective than the two pills together and more likely to cause side effects. uncomfortable.

Kacsmaryk’s conservative record

Before becoming a judge, Kacsmaryk worked as an assistant general counsel at the First Liberty Institute, a nonprofit Christian conservative legal organization. In 2015, he published articles criticizing abortion rights and same-sex marriage.

Given this record, abortion rights advocates have accused the Hippocratic Medicine Alliance of “forum shopping” – taking legal action in a jurisdiction seen as favorable to a cause.

The group was registered in Amarillo in August 2022, three months after the Supreme Court overturned Roe v. Wade. Kacsmaryk is the sole judge in the Amarillo Division of the Northern District of Texas and hears all civil cases there.

“Before another judge, this case would never have seen the light of day and would have been thrown out on procedural grounds,” Duffy said.

How abortion providers plan to respond

Mifepristone blocks the hormone progesterone, while misoprostol induces contractions. The two-drug regimen is approved for terminating pregnancies up to 10 weeks. Patients typically take one tablet of mifepristone, followed by four to eight tablets of misoprostol at least 24 to 48 hours later.

“Medical abortion is incredibly safe. It’s safer than Tylenol,” said Amy Hagstrom Miller, founder of Whole Woman’s Health, which operates abortion clinics in several states, including Maryland, Minnesota and Virginia. “What we have here is people politics mixed with science.”

Abortion providers said they were worried about confusion and misinformation if the judge granted the injunction request, though their main concern was the potential effects on the women’s health. On its own, Miller said, misoprostol is “not as comfortable for patients,” as they may experience nausea, diarrhea, chills, vomiting, or more severe cramping as side effects.

Misoprostol may also be less effective when taken alone, making some abortion providers reluctant to rely on it.

“I would be very hesitant to use off-label misoprostol,” said Dr. Dmitriy Bronfman, medical director of the Brooklyn Abortion Clinic.

Studies have shown that success rates for misoprostol typically range from 80% to 95%. Together, mifepristone and misoprostol can be up to 99.6% effective in terminating a pregnancy, according to a 2015 study.

Joanna Swanson

Joanna Swanson is Europe correspondent at the Thomson Reuters Foundation based in Brussels covering politics, culture, business, climate change, society, economies and inclusive tech. With specific focus in breaking news, she has covered some of the world's most significant stories.