ARI SHAPIRO, HOST:
First to the Supreme Court, which entered the abortion debate again today. It agreed to review a lower court decision that would make the commonly used abortion pill mifepristone less accessible. A Supreme Court decision on this case, which would come next year, could not only affect the way the FDA does its job, but also have a major impact on the presidential election. NPR politics correspondent Danielle Kurtzleben and pharmaceuticals correspondent Sydney Lupkin are here to explain what is at stake. Good to have you both with us.
SYDNEY LUPKIN, BYLINE: Hey, Ari.
DANIELLE KURTZLEBEN, BYLINE: Hi.
SHAPIRO: Danielle, let's start with you. Tell us about the case the Supreme Court's going to hear.
KURTZLEBEN: Sure. So this case is about the availability of mifepristone, which is one of two drugs used in medication abortions. In this case, an antiabortion rights group called the Alliance for Hippocratic Medicine brought a suit against the FDA, in part arguing against regulations on mifepristone that have been loosened over time. They don't think it should have been loosened. Starting in 2016, there were a number of changes. For example, the FDA made prescriptions available via telemedicine and made it possible to send the pills to patients through the mail. Now, in this case, the Fifth Circuit Court of Appeals said those regulations shouldn't have been loosened. They agreed with the plaintiffs. They said that the drug shouldn't be so widely available.
Now, had the Supreme Court not decided today to take this up, that would mean those tighter curbs on the drug would stand. But since they will take this up, mifepristone will remain available for now, in its current form. But a Supreme Court ruling, when it comes, could mean tighter restrictions on the drug, or it might not. It totally depends.
SHAPIRO: OK, so the drug is still available...
KURTZLEBEN: Yes.
SHAPIRO: ...For now at least. But, Sydney, what are the stakes here? What could change?
LUPKIN: Yeah, I mean, mifepristone is, like Danielle said, used in medication abortions. And those now account for more than half of abortions in the United States. The drug was approved in 2000, and it was a big deal in the U.S. because it was the first time women here could end their pregnancies without needing to undergo a surgical procedure. But globally, it actually wasn't a groundbreaking approval. Mifepristone had been approved up to a dozen years in other countries by that point. So there was plenty of evidence it was safe and effective. And of course, there's even more now that it's been approved in the U.S. for 23 years.
Overall, mifepristone increases access to abortion care and can currently be used up to 10 weeks gestation. Rolling back that approval to these pre-2016 restrictions would limit that access. The drug works by blocking a hormone needed for pregnancy to continue - that's called progesterone. And it's usually taken with a second drug, misoprostol, 24 hours later, which causes the uterus to contract and then empty.
SHAPIRO: But misoprostol's approval is not on the chopping block, right?
LUPKIN: Right. That's right. This is just about mifepristone. There are misoprostol-only abortions, and those could continue even if the court tightens restrictions on mifepristone. But misoprostol-only abortions are considered less effective and more painful than abortions using both drugs together. And if this case is successful, abortion opponents could come up with a way to take action against misoprostol next.
SHAPIRO: This opinion could come two years after the Supreme Court overturned Roe v. Wade. Danielle, how much could this case further change the abortion landscape in the U.S.?
KURTZLEBEN: Very, very much, in a really huge way. Like I said earlier, this ruling, depending on how the justices rule - it could mean that patients can get the drug less easily. For example, if justices decided to roll back regulations to that pre-2016 status, it could mean, for example, that pills aren't sent through the mail anywhere, even in states where abortion is legal right now. And this would also be a huge deal, particularly for patients in states where abortion is tightly restricted, because right now, those patients can still get the pills through the mail.
So one way to think about this very simply is this - is that the Dobbs ruling overturning Roe sent abortion back to the states. States could determine, up to a point, what their abortion laws look like. This case would, in some ways, affect abortion availability nationwide. That is a really big deal. But there's one other thing to note here - is that, yes, the justices could tighten the restrictions or not. But they could also simply say, according to legal scholars, that plaintiffs didn't have legal standing here - that this was not their case to bring - now, in which case the justices wouldn't rule on the legality of the arguments that they're making. They would just say regulations stay where they are right now. We're not really taking this up.
SHAPIRO: Sydney, you cover the pharmaceuticals industry. What could this mean for drug companies?
LUPKIN: So this would set a precedent for court interference in FDA expert decision-making. For decades, the FDA has been the global leader in approving countless drugs based on rigorous safety and efficacy standards. And now a court - not the FDA's doctors and scientists - a court could undo that. Here's Professor Robin Feldman at the University of California Law in San Francisco.
ROBIN FELDMAN: If the decision is broad enough to leave room to challenge all of those, the agency could be under considerable assault in the years to come.
LUPKIN: The FDA doesn't want to be sued. For one thing, it's expensive, so it could make the agency more cautious when it comes to drugs that are politically charged. Think drugs for HIV, drugs for gender-affirming care. And companies might not want to invest in developing some drugs if, even after meeting FDA standards and winning that approval, the approval can just be undone or limited by the courts. So it makes that business investment a lot more risky. And the industry has argued that it will have a chilling effect on innovation.
SHAPIRO: And then there's the politics.
KURTZLEBEN: Right.
SHAPIRO: If the Supreme Court decides another landmark abortion case during a presidential election year, Danielle, what could that mean?
KURTZLEBEN: It could mean a lot. It depends, of course, on how they rule. But one thing we know from the 2022 midterms, right after the Dobbs decision, and also that we know from this year's off-year elections - for example, in Virginia - is that abortion, right now, at least, really gets Democrats and Democratic-leaning voters really fired up. They are very upset about the overturning of Roe, of course. So were the Supreme Court to tighten those rules on mifepristone, it would be a huge blow for pro-abortion rights groups, and Democrats would also definitely run on abortion rights. We already know this.
For example, the Biden campaign put out a statement today. It says MAGA Republicans, led by Donald Trump, are marching this country toward a full-on national abortion ban. And if the Supreme Court strips away access to safe and effective medication abortion next year, it will be the latest step towards achieving that goal. That is very strident language from the Biden campaign. You can bet this would become an absolutely huge issue in the 2024 presidential election if the Supreme Court decided to restrict the pills, which, again, we're going to have to see next year.
SHAPIRO: But we know, as of today, they are at least going to hear the case.
KURTZLEBEN: Correct.
SHAPIRO: Reporting there from NPR is Danielle Kurtzleben and Sydney Lupkin. Thank you both.
LUPKIN: Thank you.
KURTZLEBEN: You bet. Transcript provided by NPR, Copyright NPR.
NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.
