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Supreme Court allows abortion pill to stay on the market for now

The Justice Department and Danco Laboratories, which makes the brand version of mifepristone, Mifeprex, had asked the court to step in immediately.
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WASHINGTON — The Supreme Court on Friday allowed the most commonly used abortion pill in the U.S. to remain widely available.

The court blocked in full a decision by Texas U.S. District Judge Matthew Kacsmaryk on April 7 that had invalidated the Food and Drug Administration’s longtime approval of mifepristone and handed a sweeping victory to abortion opponents.

Two of the nine justices — conservatives Clarence Thomas and Samuel Alito — said they would have let part of Kacsmaryk's ruling take effect.

The Justice Department and Danco Laboratories, which makes the name brand version of mifepristone, Mifeprex, had asked the justices to step in after a federal appeals court kept in place a number of provisions in Kacsmaryk's order that would have imperiled widespread access to the drug, including restrictions on distributing the pill to patients by mail.

A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kan., on Oct. 12, 2022.Charlie Riedel / AP file

The court, which has a 6-3 conservative majority, issued a temporary stay of Kacsmaryk's ruling April 14, which was extended for two days Wednesday while the justices considered what steps to take.

Alito said in a brief dissenting opinion Friday that a decision to suspend regulatory changes made since 2016 would not have prevented mifepristone from being available.

"At present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim," Alito wrote.

"Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone," he added.

The court's decision means women can still obtain mifepristone by mail, take it at home and use it up to 10 weeks into a pregnancy, as litigation continues in the lower court. The generic version of the drug, made by GenBioPro, will also continue to be available.

The case will now go back to the 5th Circuit for oral arguments before a three-judge panel on May 17. Nothing will change mifepristone’s availability in the interim.

President Joe Biden said shortly after the court's action that his administration would "continue to fight politically-driven attacks on women's health."

"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," Biden said in a statement. "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."

An attorney representing Danco welcomed the Supreme Court’s order, saying it “preserves crucial access to a drug relied on by millions of patients.”

“The lower courts’ reversal of longstanding FDA approvals has caused widespread chaos among providers, patients, and healthcare systems,” attorney Jessica Ellsworth said in a statement. “Today’s order provides continuity to all concerned as we litigate the underlying issues in this case.”

Abortion opponents, meanwhile, vowed to continue their fight against the FDA.

"The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions," said Erik Baptist, senior counsel at Alliance Defending Freedom, which represents the plaintiffs in the case.

"We look forward to a final outcome in this case that will hold the FDA accountable,” Baptist added.

The case marked a significant test for the same conservative majority that last summer overturned the landmark Roe v. Wade decision, which had ensured for 50 years a constitutional right to abortion.

The abortion pill dispute involves different legal issues about the FDA’s process for approving drugs, but the case raised questions over the court’s pledge last year that it would leave abortion policy to the states and the federal government.

A federal judge in Washington state added a further wrinkle when he issued a preliminary injunction in a different case barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”

That ruling, also issued April 7, applied to only 17 liberal-leaning states and Washington, D.C., which filed a lawsuit in February challenging the FDA’s regulations over the drug.

The 5th U.S. Circuit Court of Appeals last week had narrowed the scope of Kacsmaryk’s broader decision by declining to suspend the FDA’S original approval of mifepristone, as Kacsmaryk had done.

But in upholding other portions of his decision that addressed several steps the FDA undertook in recent years that made the pill easier to obtain, the Justice Department and Danco argued that there would still be enormous disruption to the availability of the pill.

The current labeling of pills on the market wouldn’t match the restrictions imposed by the 5th Circuit, which would render all pills on the market illegal, the Justice Department and Danco argued.

While a different drug, misoprostol, can be used alone for abortions, experts have said it is not as effective in terminating pregnancies as it is when administered in tandem with mifepristone.

A majority of abortions in the U.S. are carried out with the use of pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.

As a result of the Supreme Court’s decision to overturn Roe v. Wade, various conservative states have enacted new abortion restrictions that make it difficult if not impossible to terminate a pregnancy, whether by obtaining pills or undergoing a surgical procedure. There are 12 states where abortion is effectively banned altogether, according to Guttmacher.