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FDA approval of abortion pill ordered on hold by Texas judge

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A federal judge in Texas delivered a major blow to reproductive rights advocates Friday, ordering a hold on the U.S. Food and Drug Administration approval of mifepristone, an abortion medication used in the United States since 2000.

The ruling, which does not go into effect for seven days and is certain to be quickly appealed, could effectively prohibit use of the medication nationwide, including in California and other states where abortion is legal.

The FDA “omitted any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug,” wrote U.S. District Judge Matthew Kacsmaryk, a Trump nominee confirmed to the bench in 2019. “Considering the intense psychological trauma and post-traumatic stress woman often experience from chemical abortion, this failure should not be overlooked or overstated.”

Kacsmaryk sided with the Alliance for Hippocratic Medicine, an antiabortion group that filed suit in Texas last year arguing that the FDA had not adequately studied the safety of the drug before granting approval.

The ruling sets up a largely unprecedented legal battle over the FDA’s rigorous medication approval process.

Mifepristone is part of a two-drug combination used in more than half of all U.S. abortions, particularly those conducted early in pregnancy. Abortion providers who have been preparing for an adverse ruling say they have medical alternatives that will be available to patients.

But the elimination of a key drug used in the preferred process of completing a medication abortion, even temporarily, would represent a new front in the fight over abortion rights following last year’s Supreme Court decision reversing Roe vs. Wade.

Mini Timmaraju, president of NARAL Pro-Choice America, called a sudden prohibition on mifepristone — coming after the enactment of abortion bans in 17 states — “a perfect storm for a crisis of access and infrastructure in an already fraught environment for providers and patients.”

The Biden administration is expected to quickly appeal the ruling to the 5th Circuit Court of Appeals.

The administration is “very much concerned about this challenge to FDA authority and want to fight it in the courts as robustly as possible,” said Kirsten Moore, executive director of the EMAA Project, which advocates for access to medication abortion.

The standard protocol for an abortion via medication is a combination of two pills — mifepristone to end the pregnancy and misoprostol to cause cramping and bleeding to empty the uterus. The combination is used in 98% of medication abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

Concerned that pregnant patients may be confused about their options in the wake of the decision, abortion providers and advocates stress that medication abortion is still available.

“We are ensuring at the state level that we — not only Planned Parenthood but all abortion providers that provide medication abortion in California — have the option of switching to a [misoprostol]-only protocol if that becomes necessary in light of the decision and subsequent actions by the FDA,” said Lisa Matsubara, general counsel and vice president of policy at Planned Parenthood Affiliates of California.

Misoprostol by itself is safe and effective, although not as effective as when the two drugs used together.

A 2019 study found that the two-drug combination was 95% effective at ending a first trimester pregnancy, while misoprostol alone was 78% effective, although higher when multiple doses were administered.

As of mid-2022, about 5.6 million women have used mifepristone in the United States, according to the FDA.

The agency’s 2000 approval of mifepristone, also known as RU-486, was controversial at the time and came after years of public debate over the drug, which had already been approved and in use in Europe. FDA approved the drug with limitations to how it could be distributed. Many of those restrictions have been repealed in recent years.

The Alliance for Hippocratic Medicine filed the case in Amarillo, Texas, in hopes of landing it in front of a conservative judge sympathetic to their cause. The federal court in Amarillo is represented by only one judge, so plaintiffs knew Kacsmaryk would hear their case.

Kacsmaryk previously served as deputy general counsel for First Liberty Institute, a Christian conservative nonprofit group. He was one of more than 200 new federal judges placed on the bench under Trump and a Republican-controlled Senate in an acknowledged attempt by conservatives to remake the U.S. judiciary.

Civil rights groups campaigned against Kacsmaryk’s nomination, warning that he was an “anti-LGBT activist and culture warrior” who opposed same-sex marriage and abortion rights.

As a judge, Kacmaryk has blocked Biden’s plan to reverse Trump’s “Remain in Mexico” immigration policy, a ruling that forced tens of thousands of migrants seeking asylum to wait in Mexico for U.S. immigration court hearings. Last year, he ruled that teenagers need parental consent to obtain birth control and that the Biden administration overstepped its authority when it issued guidelines stating that employers that failed to accommodate transgender employees on dress codes, pronouns and bathroom facilities were guilty of sex discrimination.

Some supporters of abortion rights have called on the Biden administration and the FDA to ignore Kacsmaryk’s ruling, citing the judge’s outspoken opposition to abortion and the significant data compiled since mifepristone’s approval that show it is safe.

“The awful reality is, from the moment this case landed in front of Judge Kacsmaryk, it’s been a rigged game all along. It’s illegitimate,” said Sen. Ron Wyden (D-Ore.). “President Biden and the FDA must ignore it.”

Times staff writer Jenny Jarvie contributed to this report.

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