JUANA SUMMERS, HOST:
Mifepristone, on the market for more than 20 years in the U.S., is used in most medication abortions in the country. However, on Friday, a federal judge in Texas ruled that the Food and Drug Administration didn't properly approve this drug decades ago. Today, the Justice Department asked a federal appeals court to put the decision on hold.
Adam Unikowsky, who formerly clerked for Justice Antonin Scalia, is in private practice. He read the ruling and wrote about it over the weekend, concluding that the decision is indefensible, and it's not legally sound. Adam Unikowsky, welcome to ALL THINGS CONSIDERED.
ADAM UNIKOWSKY: Good afternoon. Thank you for inviting me.
SUMMERS: So let's just start off with your assertion that the plaintiffs here don't have any standing. Start off by explaining to us what that is legally, and why do they not have standing?
UNIKOWSKY: Sure. So the plaintiffs in this case, who are organizations of pro-life doctors, can't sue to overturn the FDA's approval of mifepristone unless they can show that they're harmed by it. However, these doctors do not prescribe mifepristone to their patients. It's other doctors who do. So the plaintiffs allege that they were harmed because, hypothetically, another doctor will prescribe mifepristone to their patient. That patient is going to have an adverse reaction. That patient will then switch doctors, go to one of the doctors who are plaintiffs in the case, which will, in turn, cause harm to the doctor treating that patient. And I simply think that's too speculative and too conjectural to establish standing under the Supreme Court's precedents.
SUMMERS: You also make the argument that this decision isn't timely. We should point out that mifepristone was approved by the FDA back in the year 2000. How does this issue of timeliness hurt the plaintiff's argument or the judge's ruling here?
UNIKOWSKY: Yeah. So the plaintiff - or one of the plaintiffs filed a petition challenging the FDA's decision, which was denied in March of 2016. So they had six years - until March of '22 - to file a lawsuit, and they didn't file a lawsuit in that span. They filed in November of '22. And so the statute of limitations has expired on the suit, in my view. The district judge disagrees, concluding that the FDA reopened the issue in 2016 and 2021, but I simply don't agree with that ruling. I don't see anything in the decisions from 2016 or 2021 purporting to reopen the FDA's 2000 decision to approve mifepristone.
SUMMERS: I mean, I am not a legal expert, but for me, this raises a question about the implications for the FDA's regulatory authority. And it seems like there could possibly be far-reaching impacts beyond just this one drug.
UNIKOWSKY: I think that's the case for a couple of reasons. First of all, the judge's ruling that a change to the conditions on the use of a particular drug reopens the underlying approval would certainly potentially undermine the FDA's regulatory regime. As well, the court essentially overturns the FDA's decision fundamentally because the court disagrees with the agency's judgment. But in federal administrative law, courts are generally supposed to defer to the expert judgments of agencies. They have the authority to overturn agencies, but they have to do that sparingly. And the judge's willingness to overturn the agency's decision, in my view, effectuates a significant transfer of power from the FDA to the judiciary.
SUMMERS: Now, the Justice Department has today filed an emergency stay motion with the 5th Circuit Court of Appeals, seeking to block this order striking down the FDA's approval of mifepristone. Tell us what that means legally and where things stand today.
UNIKOWSKY: The federal district court delayed the effect of its order for one week, so he stayed the effect of his order until this coming Friday - this week. And so the Justice Department has asked the 5th Circuit Court of Appeals to stay the district judge's ruling for more than one week - in fact, stay for the entire pendency of the appeal. So today, the Justice Department filed its motion, and then the plaintiffs will file its response. And I expect we'll get a ruling from the 5th Circuit fairly quickly.
SUMMERS: Since this news broke on Friday and over the weekend, there's been a lot of discussion about these two dueling decisions on this abortion pill - one in Texas that we've just been discussing, as well as a countermove by a Democratic attorney general in Washington state - a different ruling on the same drug. And I think, for many people, that's brought up some confusion about what is actually happening here. Can you talk a little bit about how these two rulings interplay?
UNIKOWSKY: Sure. So the ruling in Washington is an order that preserves the status quo, and it's actually not entirely clear how the rulings fit together. In fact, I understand that the Justice Department has asked the court in Washington to clarify its order and explain how it relates to the Texas order. So at this point, I think that there's a certain amount of uncertainty. As a factual matter, I expect both of the orders to go up to, you know, the relevant appellate courts, perhaps eventually to the Supreme Court in fairly short order, which should issue some clarity. I would say, right now, the situation is not entirely clear.
SUMMERS: Adam Unikowsky writes Adam's Legal Newsletter on Substack and is in private practice. Adam, thank you so much.
UNIKOWSKY: You're welcome. Thank you. Transcript provided by NPR, Copyright NPR.
