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A US judge in Texas will soon rule on the abortion pill mifepristone. what could happen here

WorldAsiaA US judge in Texas will soon rule on the abortion pill mifepristone. what could happen here
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The Alliance for Hippocratic Medicine wants Judge Kaxmariek to revoke the FDA’s medical approval of mifepristone, which would effectively ban the abortion pill across America.

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A Texas judge will soon issue an important ruling in a closely watched case challenging the Food and Drug Administration’s approval of the abortion pill mifepristone.

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The lawsuit, filed by a group of doctors opposed to abortion called the Alliance for Hippocratic Medicine, is an unprecedented case, and Judge Matthew Kaczmarik for the US Northern District of Texas could rule several different ways.

He could order the FDA to completely remove mifepristone from the US market. It’s also possible that Kacsmaryk could order the agency to impose tighter restrictions on access to mifepristone, but prevent it from halting sales entirely. The judge may also rule in favor of the FDA, but anti-abortion groups will appeal.

Kacsmaryk told attorneys involved in the case during oral arguments in Amarillo on Wednesday that he would issue his decision “as soon as possible.”

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Abortion rights groups and legal experts expect the judge to rule against the FDA in some form. Kaksmarić joined the court in 2019 after being appointed by the former president Donald Trump, His nomination was unanimously opposed by Senate Democrats as well as Republican Susan Collins of Maine over concerns about his views on abortion and LGBTQ rights.

Wendy Davis, senior advisor for Planned Parenthood Texas Votes, told reporters at a news conference on Wednesday that abortion rights activists are preparing for the worst.

Carrie Flaxman, chief of litigation at Planned Parenthood Federation of America, said the court order blocking the sale of mifepristone would have the biggest impact in states where abortion is legal.

Rachel Rebouche, an expert in reproductive health law at Temple University, said an order to stop sales would cause confusion because there would be more litigation over whether such orders are legal.

potential injunction

sharp appeal

Glenn Cohen, a health law expert at Harvard, said if Kaxmarik were to issue an order withdrawing mifepristone immediately, the Biden administration would ask him to stay the decision pending his appeal. If Kacsmaryk refuses, the administration will take the matter to the 5th US Circuit Court of Appeals.

Cohen said, “My guess is that the adjournment papers have already been prepared. Someone will be presenting them to the court within hours of the decision.”

Cohen, Rebosch and 17 other drug law experts, in a court filing in support of the FDA, told Kaxmaryk that ordering the immediate withdrawal of mifepristone would conflict with federal law.

He said the authority to withdraw a drug rests with the FDA commissioner, who decides on the basis of scientific evidence on the safety and efficacy of the drug. The manufacturer, in this case Danco Laboratories, must also be heard during the process.

“The FDA will argue that the court cannot withdraw the drug – the FDA has to withdraw the drug and the court is exempt from withdrawing the drug by federal statute,” Rebouche said.

FDA may drag out process

If Kacsmaryk decides against withdrawing mifepristone immediately and instead orders the FDA to begin its formal process for withdrawing the drug from the market, the agency may use that process assuming that it does not suspend approval during

Allison Whelan said, “Withdrawal of a drug from the market when the FDA follows those processes takes months if not years, so the FDA may try to lengthen the process a little bit more to keep the drug on the market.” Georgia State University has experts in FDA law.

“The FDA does not like to have its scientific expertise and legitimacy questioned,” said Whelan, who also signed a court filing in support of the FDA.

mifepristone off-label

strict restrictions

Kacsmaryk could also stop selling mifepristone and instead order the FDA to impose tighter restrictions on how the drug is distributed.

In January, the FDA permanently removed a requirement that patients receive mifepristone in person from a certified health care provider. This allowed telehealth appointments and delivery of mifepristone by mail.

The Alliance for Hippocratic Medicine has asked the judge to reinstate FDA restrictions that have been rolled back for years, arguing that a federal statute from 1873 called the Comstock Act prohibited abortion through the mail. Prohibits the sending of medicines.

Rebouche said the Comstock Act hasn’t been enforced in decades, but there’s a possibility the judge could try to revive the statue to force the FDA to reimpose requirements that patients make personal choices. receive mifepristone.

Correction: Allison Whelan is an expert on FDA law at Georgia State University. An earlier version had misspelled the name of the school.

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