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A Texas judge holds a crucial hearing in a case that will decide access to the abortion pill nationwide

2023-03-15T12:31:03.583Z


The federal magistrate scheduled a hearing at the request of an association of anti-abortion doctors, who want the Food and Drug Administration to revoke the approval of the drug mifepristone in the country.


By Aria Bendix and Chloe Atkins -

NBC News

A federal judge in Texas will hold a hearing this Wednesday on a lawsuit that seeks to nullify the approval by the Food and Drug Administration (FDA, for its acronym in English) of the pills used in medical abortions.

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

This request is the focus of the hearing on Wednesday, scheduled for 9:00 am (local time), although it is unknown when District Judge Matthew Kacsmaryk will make a decision, which could take place on Wednesday or in the coming days or weeks.

[California will not renew $54 million contract with Walgreens over company's decision on abortion pill]

More than half of the women who terminate their pregnancies in the United States do so by medical abortion.

If access to mifepristone is cut off, women seeking an abortion and their providers will have to choose between surgery or taking the other drug in the regimen, misoprostol, on their own.

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

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But the Biden government maintains that the group does not have the legal capacity to file the lawsuit.

That's one of the issues Kacsmaryk has asked lawyers to prepare to address at the hearing, along with the potential harm of stopping access to mifepristone and the implications of enforcing such an order across the country.

There is little legal precedent for a court to strike down a longstanding FDA approval, but abortion providers are nonetheless bracing for the possibility that Kacsmaryk - who was appointed by former President Donald Trump - will grant the request for action. precautionary, since the judge has historically taken conservative positions on the right to abortion and other issues.

Erik Baptist, senior attorney with Alliance Defending Freedom, the conservative Christian legal group representing the plaintiffs, said that "the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs."

[This Is Why Walgreens Won't Sell Abortion Pills In 20 States]

“We are not seeking a nationwide abortion ban, but rather we are targeting one means of abortion because it is dangerous, and we are holding the FDA to account for failing America's women and girls,” Baptist added.

But the Biden administration has argued in court that the FDA thoroughly reviewed the scientific evidence before approving mifepristone, and that removing it from the market would worsen the health of people seeking abortions. 

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The two-pill regimen has a 0.4% risk of serious complications, research has shown.

"Never before has FDA approval of a drug been in question like this, when the science is so clear, it's been on the market for so long, and it's so clearly safe," said Cat Duffy, a policy analyst at National Health Law. Program, which works to protect access to abortion.

[FDA authorizes abortion pills to be sold by prescription in US pharmacies]

Planned Parenthood and several abortion clinics have said that if mifepristone is withdrawn from the market, they will advise patients to take misoprostol alone, despite the fact that this method may be less effective than the two pills together and is more likely to cause side effects. annoying secondaries.

The conservative record

by Kacsmaryk

Before becoming a judge, Kacsmaryk worked as deputy 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 Alliance for Hippocratic Medicine of “

forum shopping

”, that is, of filing a lawsuit in a jurisdiction considered sympathetic to a cause. 

The group registered in Amarillo in August 2022, three months after the Supreme Court struck down 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 dismissed on procedural grounds,” Duffy opined.

The response of abortion providers

Mifepristone blocks the hormone progesterone, while misoprostol induces contractions.

This two-drug regimen is approved to terminate pregnancies up to 10 weeks.

Patients usually take one mifepristone tablet, followed by four to eight misoprostol tablets at least 24 to 48 hours later. 

“Medication abortion is incredibly safe.

It's safer than Tylenol,” said Amy Hagstrom Miller, founder of Whole Woman's Health, which runs abortion clinics in several states, including Maryland, Minnesota and Virginia.

“What we have here is the politics of the people mixed with science,” she pointed out.

Mifepristone and misoprostol pills at a medical abortion clinic. Erin Hooley / Chicago Tribune/Tribune News Service via Getty Images

Abortion providers said they are concerned about confusion and misinformation if the judge grants the injunction request, though their main concern is the potential effects on women's health.

By itself, Miller said, misoprostol "is not as comfortable for patients," as they may experience more severe nausea, diarrhea, chills, vomiting or cramps as side effects.

[Thousands defend abortion rights at the Women's March for the 50th anniversary of the landmark Roe v.

Wade]

Misoprostol may also be less effective when taken alone, making some abortion providers hesitant to trust it.

"I would be reluctant to use misoprostol too much off-label," 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 pregnancy, according to a 2015 analysis.

Source: telemundo

All news articles on 2023-03-15

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