Supreme Court stops abortion pill mifepristone restrictions from taking effect

WASHINGTON — The Supreme Court on Friday decided to preserve access to the abortion pill mifepristone, a key drug commonly used in abortions, which rejected restrictions made by a lower court.

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Update 7:20 p.m. EDT April 21: President Joe Biden released a statement on the Supreme Court’s decision over the abortion pill mifepristone.

“Today, the Supreme Court granted the Department of Justice’s emergency stay application in Alliance for Hippocratic Medicine v. FDA, preventing a lower court decision from going into effect that would have undermined FDA’s medical judgment and put women’s health at risk,” Biden said. “As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts. I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”

-- Jessica Goodman, Cox Media Group National Content Desk

Update 6:54 p.m. EDT April 21: Supreme Court justices granted emergency requests from both the Biden administration and Danco Laboratories, the company that makes the drug mifepristone, according to The Associated Press. The justices have appealed a ruling made in a lower court that would have pushed back the Food and Drug Administration’s approval of the pill.

Mifepristone will remain available for now, according to the New York Times.

Mifepristone has been approved for use in the U.S. since 2000 and more than 5 million people have used it, according to the AP. Mifepristone is used along with misoprostol in more than half of the abortions across the country.

Mifepristone and misoprostol are used together during the first 12 weeks of pregnancy, the Times reported.

-- Jessica Goodman, Cox Media Group National Content Desk

Original story: The nation’s highest court extended its deadline Wednesday to decide on access to the drug until late Friday night. In a one-sentence order, Associate Justice Samuel Alito did not share the reason for the delay.

The court is considering whether to allow continued access to mifepristone after a federal judge in Texas ordered restrictions earlier this month. U.S. District Judge Matthew Kacsmaryk ordered a hold on the FDA approval of the drug on April 7, siding with abortion opponents who argued that regulators failed to adequately review the pill’s safety risks before approving it for use in 2000.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote earlier this month in an opinion and order. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

Public health authorities have repeatedly found mifepristone to be safe and effective. Since the FDA approved of its use 23 years ago, more than 5 million women nationwide have used the drug. Medical groups have said that complications from its use are seen at a lower rate than those seen with routine medical procedures, like wisdom teeth removal and colonoscopies, The Associated Press reported. Mifepristone is also used for miscarriage management and is typically paired with another medication, misoprostol.

In a request to have the Supreme Court halt Kacsmaryk’s order, Solicitor General Elizabeth Prelogar argued that allowing it to stand “would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”

“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety -- much less done so after those conditions have been in effect for years,” Prelogar wrote. “And the lower courts reached that unprecedented result only through a series of fundamental errors that violate black letter Article III and administrative law principles.”

On Friday, the Supreme Court could decide to extend its pause of Kacsmaryk’s ruling, to extend its deadline to issue a decision or to decline to act and allow the Texas judge’s order to stand. It could also decide to take up the case itself.

The challenge is the latest abortion-related case to land before the Supreme Court following its decision to overturn the 1973 Roe v. Wade decision last year. The decision had protected abortion nationwide for decades. Since then, several states have enacted restrictions or bans on abortion access.