Abortion pill will stay on the market for now, but it could be harder to get

The matter could still be taken up by the U.S. Supreme Court.

April 13, 2023, 12:46 PM

The abortion pill mifepristone will remain on the market for now -- but come Saturday morning, access will be severely restricted while the Biden administration asks the Supreme Court to intervene in a sweeping case that could decide access to the drug nationwide, even in states where abortion is legal.

A three-judge panel on the 5th Circuit Court of Appeals ruled late Wednesday that it would partially block a lower court's ruling that would have suspended the Food and Drug Administration's approval of the drug.

It's a bittersweet victory for abortion rights advocates who feared the appeals court would side with conservative plaintiffs in the case entirely and force manufacturing and production of the drug mifepristone to stop by the weekend. Instead, the judges agreed to allow the drug to stay on the market -- at least temporarily while the case is considered. But it also called to reimpose tough restrictions on how the drug is provided to patients, including limiting it to seven weeks of pregnancy and a prohibition on mailing the drug.

Such restrictions haven't been in place since 2000 when it was first approved and regulators wanted to monitor the drug's safety record more closely.

Unsatisfied, Attorney General Merrick Garland said Thursday the administration would appeal the ruling to the Supreme Court. If the Supreme Court agrees to consider the case, it would be the second time the conservative majority would consider abortion rights after last year's landmark ruling on Dobbs v. Jackson Women's Health Organization that returned the decision of abortion rights to the states.

"This is not a win," said Kirsten Moore, director of the Expanding Medication Abortion Access (EMMAA) Project, a group dedicated to ensuring access to the abortion pill. "They rolled back the clock to 2000. That's not winning, especially in a post-Dobbs world."

Abortion rights opponents said they were pleased with the decision by the 5th Circuit because it paves the way for approval of the drug to be suspended entirely.

“We are very encouraged by this landmark win for women and girls. The Court recognized that the abortion pill is dangerous and rolled back Biden’s reckless mail-order abortion scheme," said Katie Daniel, the state policy director for Susan B. Anthony Pro-Life America."

Unless the Supreme Court intervenes quickly, the drug as of Saturday morning will be available but only up to seven weeks instead of 10 weeks of pregnancy.

Three in-person office visits would also be required: the first to administer mifepristone, the second to administer misoprostol -- which causes the pregnancy to be expelled -- and the third to assess any complications and ensure there were no fetal remains in the womb.

And, clinics would need to provide a qualified physician to oversee administering the drug and report any adverse effects.

PHOTO: Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, N.M., Jan. 11, 2023.
Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, N.M., Jan. 11, 2023.
Evelyn Hockstein/Reuters, FILE

While the appeals court's decision is temporary until the case can be considered in full, the 5th Circuit judges signaled it was sympathetic to conservative arguments made in the lawsuit, calling the FDA rules around mifepristone "exceedingly unusual" because they allow patients to obtain the drug without seeing a doctor in person.

"Because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way," the panel of appeals court judges wrote.

Danco Labs, which produces the brand name version of the drug Mifeprex, said the FDA's decisions in recent years to loosen regulation of the drug were based on safety and efficacy data.

"FDA has been empowered by Congress to make decisions about what drugs are safe and effective and how they should be available to patients," the company wrote in a statement. "Danco remains unchanged in its commitment to do all that we can to support and protect the availability of and access to Mifeprex for healthcare providers and all people in the United States."

ABC's Devin Dwyer and Sarah Kolinovsky contributed to this report.

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