AILSA CHANG, HOST:
We're going to turn now to news from the Supreme Court, which today postponed a ruling on mifepristone. That's the drug used in medication abortions. Meanwhile, one of the manufacturers of the generic form of the drug filed suit against the Food and Drug Administration in an effort to preserve access to the drug while federal litigation threatens to overturn its FDA approval.
Joining us now is NPR legal affairs correspondent Nina Totenberg. Hi, Nina.
NINA TOTENBERG, BYLINE: Hi there, Ailsa.
CHANG: OK. That was a lot, what I just said. What is going on here?
TOTENBERG: (Laughter) I think you could fairly say that, every day, things get messier and messier.
CHANG: Yeah. So remind us how we even got here.
TOTENBERG: Well, the latest clash over abortion began nearly two weeks ago in Texas, when federal District Judge Matthew Kacsmaryk imposed a nationwide ban on mifepristone by declaring that the FDA had improperly approved the drug 23 years ago. Within minutes of that decision, federal Judge William (ph) Rice in Washington issued a contrary ruling, ordering the FDA rules to remain in place for part of the country. Five days later, the case became even more complicated when the 5th Circuit Court of Appeals, which covers Texas, partially narrowed the ruling from Judge Kacsmaryk.
The appeals court said that because the statute of limitations for challenging FDA approval of the drug had long ago passed; the drug could still be used under the original terms of its approval. That is, it could be used for up to seven weeks, not the 10 weeks that it has subsequently been approved for by the FDA. In addition, the appeals court rolled back other rules that the FDA has approved since 2015, governing how the drug can be used.
CHANG: OK. And what are those newer rules?
TOTENBERG: Over the last seven years, the FDA has either conducted or reviewed dozens of studies in clinical trials. And based on those, the agency now allows telemedicine appointments. It allows obtaining the drug by mail. And the standard dose of mifepristone is now one-third the strength of the original dose approved 23 years ago.
CHANG: OK. And then after the 5th Circuit ruled, the Biden administration, representing the FDA, appealed to the Supreme Court. So where are we now on all of that?
TOTENBERG: Well, last Friday, Justice Alito, who's the justice in charge of emergency appeals from the 5th Circuit, ordered both sides to submit briefs as to whether to grant an emergency stay, and he ordered what's called an administrative stay, a temporary pause until midnight tonight, which the court has now extended to Friday midnight.
CHANG: OK. So the suspense continues. What are the options before the court right now?
TOTENBERG: Well, look, at this point, I think it's a little bit like covering the Kremlin.
(LAUGHTER)
TOTENBERG: Option No. 1 - block the lower court orders, but allow the 5th Circuit to go ahead and hear the expedited arguments, which it's already scheduled for May 17. I doubt the 5th Circuit's going to dramatically change its mind, but at least there would be full briefing and arguments, and in all likelihood the case would end up back at the Supreme Court by next fall. Option 2 would be for the court to block the lower court orders and then hear the case itself, either on an expedited basis in June or at - early next term. Option 3 would be to deny the emergency stay requested by the FDA and Danco Labs, the largest maker of generic mifepristone. Were that to happen, they warn, it would create regulatory chaos, jeopardizing access to mifepristone even in states where abortion is legal.
CHANG: So any guess on what option the court will take?
TOTENBERG: Well, look; if there was a clear consensus on this at the court, I think the justices would have acted today. All I can tell you is that during the early days of the pandemic, when some abortion rights activists were trying to ease restrictions on access to abortion pills, the court's conservatives deferred to the FDA's expertise. In fact, in 2020, Justice Alito, who would later author the decision overturning Roe, he expressed amazement that, quote, "a district court judge in Maryland" - in that case - "took it upon himself to overrule the FDA on a question of drug safety."
CHANG: That is NPR's Nina Totenberg. Thank you, Nina.
TOTENBERG: Thank you. Transcript provided by NPR, Copyright NPR.
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