Abortion pill can remain on market but with restrictions, appeals court rules

The common abortion pill mifepristone will remain available to patients, but with restrictions, a federal appeals court ruled on Wednesday.

However, the decision from the U.S. Court of Appeals for the 5th Circuit will remain on hold until the Supreme Court decides whether to take up the case, meaning access to the pill remains unchanged.

The case marks the highest stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last year. The Justice Department said it plans to appeal Wednesday’s decision to the high court.

Mifepristone is widely used across the U.S. to end a pregnancy in the first 10 weeks of gestation, and was first approved in 2000. About half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. It is also used to help manage miscarriages. 

The three-judge panel ruled 2-1 that mifepristone and its generic counterpart can stay on the market, with Judge James Ho advocating the drug’s original approval should have been invalidated. 

The panel voted 3-0 that changes the Food and Drug Administration made since 2016 to ease access to the drug were not allowed because the agency did not follow proper procedure.

Those changes included increasing the gestational age when mifepristone can be used up to 10 weeks of pregnancy rather than seven, allowing the medication to be mailed to patients, lowering the dosage, and permitting providers other than physicians to prescribe the drug. 

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time,” Judge Jennifer Elrod wrote. 

The ruling is a partial victory for the Biden administration, in that the conservative court said it would allow the drug to remain on the market. The panel also said the generic version can stay on the market, even though FDA approved it after 2016.

“As the Attorney General has said before, the Justice Department is committed to defending the FDA’s scientific judgment and protecting Americans’ access to safe and effective reproductive care,” a Justice Department spokesperson said in a statement. “The Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA and will be seeking Supreme Court review of that decision.”

But the ruling essentially turns the clock back in favor of a group of anti-abortion providers represented by the religious conservative legal powerhouse Alliance Defending Freedom.

Any changes to mifepristone are unlikely to take effect for weeks as the case likely returns to the Supreme Court. 

After U.S. District Judge Matthew Kacsmaryk, a Trump appointee, blocked mifepristone from the market in April, his ruling was quickly appealed. 

The 5th Circuit agreed to put on hold part of Kacsmaryk’s ruling as it considered the case, and the Supreme Court later granted the Biden administration’s request to pause the remaining portions.

Justices Clarence Thomas and Samuel Alito, two of the Supreme Court’s leading conservatives, said at the time they would have allowed the rollbacks to take effect.

Now, the case is all but certain to head back to the justices on the merits.

The parties have 90 days to appeal the latest ruling to the Supreme Court, and the justices will then consider whether to take up the dispute, a process that typically takes weeks, if not longer. 

The three judges on the 5th Circuit panel were appointed by Republican presidents. During oral arguments in May, they all indicated a willingness to restrict access to the drug.

They ultimately handed a partial victory to the FDA, but only on procedural arguments.

The Justice Department and the drug’s manufacturer contended the challengers waited too long to sue over mifepristone’s original approval, and the panel agreed. 

The judges further ruled the plaintiffs did not show enough harm to have legal standing to challenge the approval of the generic version.

In a statement, the generic manufacturer GenBioPro said even though generic mifepristone remains lawfully available, “we remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the US Food and Drug Administration’s regulatory authority.”

On the aspects where the court did reach the merits of mifepristone’s safety and the FDA’s authority, they sided with the challengers.

FDA and manufacturer Danco Laboratories, which makes the brand name version called Mifeprex, argued the lawsuit would harm women’s health. They said it was an unprecedented challenge to FDA’s drug approval authority and opened the door to challenges based entirely on political views.

But the court pushed back on those arguments.

“Their message is simple: The scientists at the FDA can do no wrong. So courts have no business reviewing their actions. That’s mistaken on multiple levels,” Ho wrote in a separate opinion.

Updated 5:18 p.m.