A Texas federal judge on Friday dealt a heavy blow to reproductive rights advocates and ordered a suspension

U.S. Food and Drug Administration approval of mifepristone, an abortion drug used in the United States since 2000.

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which does not take effect for seven days and which will surely be appealed quickly,

could effectively ban the use of the medication nationwide, including in California and other states where abortion is legal.

The FDA omitted any evaluation of the drug’s psychological effects or any evaluation of the drug’s long-term medical consequences, the U.S. district wrote.

Judge Matthew Kacsmaryk

, confirmed a 2019 Trump nominee on the bench. Given the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or overstated. Kacsmaryk

sided with the Alliance for Hippocratic Medicine, an anti-abortion group that filed a lawsuit last year in Texas arguing that the FDA had not adequately studied the drug’s safety before granting approval.

The ruling sparks a largely unprecedented legal battle over the FDA’s rigorous drug approval process.

Mifepristone is part of a two-drug combination used in more than half of all abortions in the US, especially those performed early in pregnancy. Abortion providers who have prepared 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 drug abortion, even temporarily

j, would

represent a new front in the fight over abortion rights following last year’s Supreme Court decision that reversed Kuit versus Wade.

Mini Timmaraju, president of NARAL Pro-Choice America, called a sudden ban on mifepristone following the implementation of abortion bans in 17 states the perfect storm for a crisis of access and infrastructure in an already fraught environment for healthcare providers and patients.

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

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

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

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

We are ensuring at the state level that not only Planned Parenthood, but all abortion providers offering drug-assisted abortion in California have the option to switch to a [misoprostol]– protocol only if it becomes necessary in light of the FDA’s decision and subsequent actions, said Lisa Matsubara, general counsel and vice president of policy at Planned Parenthood Affiliates of California.

Misoprostol is safe and effective on its own, although not as effective as when the two drugs are used together.

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

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

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

The Alliance for Hippocratic Medicine filed the case in Amarillo, Texas, hoping to take it to a conservative judge sympathetic to their case. 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 of First Liberty Institute, a nonprofit Christian conservative organization. He was one of more than 200 new federal judges benched under Trump and a Republican-controlled senate in an acknowledged effort by conservatives to reshape the U.S. judiciary.

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

As a judge, Kacmaryk has blocked Biden’s plan to reverse Trump’s immigration policy to stay in Mexico. Last year he ruled that teens need parental consent to get birth control and that the Biden administration went too far

his authority

when it issued guidelines stating that employers who failed to accommodate transgender employees in terms of dress code, pronouns and sanitation were guilty of sex discrimination.

Some abortion rights advocates have called on the Biden administration and the FDA to ignore Kacsmaryk’s ruling, citing the judges’ outspoken opposition to abortion and the important data gathered since the approval of mifepristones showing it is safe .

The awful reality is that ever since this case landed before Judge Kacsmaryk, it’s been a rigged game all along. It is illegal, said Sen. Ron Wyden (D-Ore.). President Biden and the FDA should ignore it.

Times staff writer Jenny Jarvie contributed to this report.