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What happens next for mifepristone in the courts

Published April 22, 2023 at 5:18 PM EDT

ADRIAN FLORIDO, HOST:

The U.S. Supreme Court has ruled the FDA-approved abortion pill mifepristone will remain widely available for now. The court blocked lower court rulings, which banned or restricted the drug. The case is now back in the hands of the 5th Circuit Court of Appeals and will almost certainly end up back at the Supreme Court. Joining us to explain what happens next is Julie Rovner with KFF Health News. Julie, Hi. Welcome back to ALL THINGS CONSIDERED.

JULIE ROVNER: Thanks.

FLORIDO: First, what did the Supreme Court ruling say?

ROVNER: So the justices didn't rule on the case challenging the abortion pill itself. They were only asked to decide whether or not the drug could remain on the market while the case continues in the lower courts. And the justices, in a one-paragraph ruling, said it can stay on the market as it is now, at least until the merits of the case work their way back to the Supreme Court. That, of course, could be weeks or months from now. So even though it will be available for now, the ultimate fate of the pill is far from decided.

FLORIDO: OK. So basically, it's been sent back to the 5th Circuit Court of Appeals, which has already ruled that the drug should remain on the market, but with more restrictions than are currently in place. Arguments are scheduled for May. What is the court likely to hear?

ROVNER: So in 2016, the FDA began to relax some of the previous restrictions on how the drug can be prescribed and delivered. That was based on newer evidence demonstrating its safety and effectiveness. As of today, the abortion pill regimen is approved for terminating pregnancies up to 10 weeks. It was seven weeks before, and the agency relaxed a rule that the drug had to be taken in the physical presence of a doctor. Instead, it could be prescribed via telemedicine and sent through the mail. The FDA more recently said that mifepristone could also become available at some pharmacies, but that hasn't happened yet.

So what the appeals court said is that the drug should stay on the market while the court case continues, but the FDA should reinstate all those restrictions that were in place in 2016. Drug experts say that in some ways, that would be even worse than banning it altogether because the rules would be based on old science. And there's one big question mark - the generic version of mifepristone wasn't approved until 2019. So would that approval be canceled? I've talked to a lot of drug and legal experts this week, and nobody seems quite sure of anything.

FLORIDO: And there are also other lawsuits - 17 states where abortion is legal are suing to keep the pill on the market. And a federal judge in Washington state has already ruled in their favor in that case. So this sounds pretty complicated.

ROVNER: It's very, very complicated. Not only are there two district court decisions that call for the FDA to take contradictory actions, but now the drug company that makes the generic version of the pill has filed its own lawsuit. GenBioPro, whose product is used in many more medication abortions than even the brand-name drug, says it would suffer catastrophic harm if its 2019 approval is rescinded.

Also, two big things to remember about this case and why it's not just about abortion - mifepristone is also used to treat women who've had miscarriages. If it's not available, patients might need surgical procedures instead. And at the same time, the drug industry is terrified that if a judge with no scientific or medical training can overrule the findings of the FDA's expert, that could open the door to other lawsuits challenging other drugs that might be controversial, things like vaccines or medications to treat or prevent HIV.

FLORIDO: OK. Julie Rovner with KFF Health News. Thanks so much, Julie.

ROVNER: Thank you. Transcript provided by NPR, Copyright NPR.

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