LEILA FADEL, HOST:
After oral arguments, several Supreme Court justices seemed skeptical about a challenge to the abortion pill mifepristone. That includes Justice Neil Gorsuch, who previously ruled in favor of overturning Roe v. Wade.
(SOUNDBITE OF ARCHIVED RECORDING)
NEIL GORSUCH: This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action.
FADEL: What Gorsuch implies there is that the anti-abortion doctors who have brought the case to the Supreme Court lack the legal standing to bring the claim. To explain what that means, we're joined by Eva Temkin. She's a former policy expert with the Food and Drug Administration and handles FDA cases at the law firm Paul Hastings. She was listening to the hearing yesterday and joins us now. Good morning.
EVA TEMKIN: Good morning.
FADEL: So how did you interpret yesterday's hearing and the skepticism we heard from Gorsuch and other justices about these arguments?
TEMKIN: You know, I interpreted the - really all of the justices coming at this, with the possible exception of Justice Alito, as expressing a good deal of skepticism that these physicians were appropriately in court on this issue. And the fundamental question that they're grappling with on the what we're calling standing is really, were these physicians injured by FDA's action on this drug? And if so, if they were, in fact, injured - and I think that's where we see a lot of the skepticism - was that injury the result of the FDA approval actions that are in question here? And I think we saw skepticism on both of those fronts from the court yesterday.
FADEL: Now, is the court questioning whether this case should be in front of them at all?
TEMKIN: Well, the court's not questioning the appeals process that brought the case to them. I think they're more questioning the original...
FADEL: OK.
TEMKIN: ...Decision in the district court and whether these plaintiffs had standing to bring the challenge in the first place.
FADEL: And what are the lawyers for the plaintiffs in this case actually arguing?
TEMKIN: They appear to be arguing that these physicians have been injured or will be injured by the very remote - and I think we heard from the solicitor general and counsel for Danco that these - this chance is actually potentially impossible, if not extremely remote. But their position is that these physicians may eventually, notwithstanding the fact that they don't prescribe this drug and they don't have patients who take this drug, be in the position of having to treat someone who was prescribed the drug by another physician and took the drug and then ended up in an emergency room in which they happened to be working.
FADEL: What are the larger implications of this case when it comes to the FDA's role in approving the use of drugs and its regulatory powers?
TEMKIN: I think that that's really the heart of the FDA law question here, right? What are the circumstances under which FDA has the authority to change a drug's approval status to keep pace with science? What you saw here was after 15 years of safe use and after 15 years of approval, FDA, in conjunction with the drug's sponsor, making changes to update the label. And the plaintiffs here are arguing that FDA did not have the authority to do that or they - that they somehow misinterpreted the scientific data that was in front of them at the time.
FADEL: Now, if they were to win this case, could this potentially impact other drugs beyond mifepristone? I mean, what happens, and what precedent does it set?
TEMKIN: Absolutely. I think it sets a - it would set - and I'm hopeful that it won't, but it would set a very, very difficult precedent for the entire pharmaceutical industry. I think that's why you've seen the industry itself step up and really sound alarm bells here. And a big part of that is that the lower court's reasoning would create a lot of friction, really drastically slow or even completely undermine FDA's ability and industry's ability to make appropriate label and drug usage updates and keep pace with science and, you know, essentially freezing drugs in time and potentially even limiting patient access to new and improved medicine options.
FADEL: Eva Temkin is a former policy expert with the FDA and handles FDA cases at the law firm Paul Hastings. Thank you for your time, Eva.
TEMKIN: Thanks for having me. 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.