Supreme Court temporarily keeps FDA abortion pill rules in place

WASHINGTON - The Supreme Court said Friday it was temporarily keeping in place federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.

In an order signed by Justice Samuel Alito, the court asked both sides to weigh in by Tuesday over whether lower court rulings restricting the Food and Drug Administration’s approval of the drug, mifepristone, should be allowed to take effect while the case works its way through federal courts. The order suggests the court will decide that issue by late Wednesday.

The justices are being asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by an appellate ruling Wednesday, can be in force while the case continues.

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The Biden administration and New York-based Danco Laboratories, the maker of the pill, asked the justices to intervene.

The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward.

Earlier, the Justice Department and Danco Laboratories both warned of "regulatory chaos" and harm to women if the high court doesn't block an appeals court ruling in a case from Texas that had the effect of tightening Food and Drug Administration rules under which the drug, mifepristone, can be prescribed and dispensed.

The new limits would take effect Saturday unless the court acts before then.

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"This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone," Solicitor General Elizabeth Prelogar, the Biden administration's top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.

A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the justices should reject the drugmaker's and the administration's pleas and allow the appeals court-ordered changes to take effect.

The fight over mifepristone lands at the Supreme Court less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.

The justices are being asked for a temporary order to keep in place Food and Drug Administration regulations governing mifepristone. Such an order would give them time to more fully consider each side’s arguments without the pressure of a deadline.

The Biden administration and Danco, which is based in New York, also want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.

The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.

A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks.

Still, the appeals court did not entirely withdraw FDA approval of mifepristone while the fight over it continues. The 5th circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.

"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.

Erin Hawley, a lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.

"The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place," said Hawley said, a senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.

It’s unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.

The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for now to allow oral arguments in the case..

The appeals court judges in the majority in Wednesday’s decision noted that the Biden administration and mifepristone’s manufacturer "warn us of significant public consequences" that would result if mifepristone were withdrawn entirely from the market under the lower court ruling.

But the judges suggested FDA changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be "difficult" to argue the changes were "so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years" the judges wrote.

Use of medication abortion jumped significantly after the 2016 rule expansion, according to data gathered by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medication abortion accounted for 39% percent of abortions but by 2020 had increased to become the most common method, accounting for 53% of all abortions.

Experts have said the use of medication abortion has increased since the court overturned Roe.

When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug.

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now. At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The panel overturned multiple decisions made by FDA regulators after years of scientific review.

Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires surgery to stop.

Still, in loosening restrictions on mifepristone, FDA regulators cited "exceedingly low rates of serious adverse events." More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one tenth of 1% of women who took the drug.

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Associated Press writers Paul Weber in Austin, Texas, and Lindsay Whitehurst in Washington contributed to this report.

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