FDA regulations on abortion pill mifepristone escalates debate between judges, activists

Yahoo Finance's Anjalee Khemlani and Alexis Keenan join the Live Show to discuss the feud between judges and activists over the abortion pill mifepristone, and whether the FDA provided all information and precautions surrounding the drug.

Video Transcript

- A group of doctors and religious organizations were in court yesterday in a closely watched case, trying to roll back the FDA's relaxed approvals on an abortion medication, mifepristone. The Supreme Court has already paused changes to the drug's approvals while the suit plays out. A conservative panel of judges in New Orleans appeals court heard their arguments. Yahoo Finance's Anjalee Khemlani and Alexis Keenan join us now for a breakdown of where we stand. Alexis, you want to start?

ALEXIS KEENAN: Yeah, so let's just first talk about who the parties are in this case. You have the plaintiffs. They are a group of doctors and a group of medical organizations and religious organizations who say that the FDA's relaxed approvals, right-- this is after mifepristone was originally approved. They say that it's causing injury to them because they're having to treat women who take the drugs and then end up in the emergency room, and then those doctors have to treat those patients. They say they don't want to do that.

On the other hand, you have the defendants, who are the FDA, as well as Danco, who is one of the manufacturers of the brand name mifepristone, and they say that this case shouldn't even be in court, that the plaintiffs aren't the right people to be here, and they lack standing, a legal term that allows the case to go forward. They also say that the FDA's approval is absolutely safe and that this medication should be on the market the way that it is.

As of now, the Supreme Court has in place a pause to keep the status quo while this case plays out. But it's important to note that this case isn't about taking the drug off the market. That's not where we are. The Fifth Circuit court of Appeals has already said that the plaintiffs' challenge to that original approval by the FDA, all the way back in 2000, that that is time barred. The plaintiffs didn't bring their suit early enough in order to keep that issue at hand.

What they're talking about are these changes in 2016, and you can see them there on your screen. After that 2000 approval, 2016, the FDA made these relaxed access to the drug, and they did things like they changed the days of gestation. They went from 49 days, where you were allow to use this medication, up into 70 days.

They also changed some things about whether women had to go for in-person doctor visits and also whether they needed to have a post-treatment exam. Also changed the dosages. They went from 600 milligrams dose to 200, so they brought it down. And then later, in 2021, during the COVID-19 pandemic, they opened up access so the prescription could be mailed to women. They don't have to be there in person.

ANJALEE KHEMLANI: And that also opened up the door to telemedicine. So what this really sets up is a discussion about whether or not the FDA decided to expand access with enough data, with enough medical data, clinical data, et cetera, to back it up, and if they're safe that way. And this plays on the issue that many of the companies and, really, the industry at large is worried about, which is questioning FDA authority. And so you heard Judge Ho really hit on that note yesterday. Listen to what he had to say.

JAMES HO: I don't understand this theme the FDA can do no wrong. First of all, you'll agree that is basically the narrative you all are putting forth. Nobody should ever question the FDA. This is unprecedented. The FDA, just last month in response to litigation about the drug, a subpart H drug for pregnant women, Makena, FDA withdrew it in response to a New York Times headline, "FDA rushed a drug for preterm births. Did FDA put speed over science?"

Just last year, Senator Murray, chairman of-- chair of the Senate Health Committee, criticizes the FDA for, quote, "unacceptable longstanding food safety failures." The FDA is being blamed for the opioid crisis.

- Your Honor--

JAMES HO: "AMA Journal of Ethics" article, how FDA failures contributed to the opioid crisis. None of this has anything to do with this case. What I'm trying to say is, why are we-- it's a theme that you all are putting forth that is completely unnecessary. We are allowed to look at the FDA just like we're allowed to look at any agency. That's the role of the courts.

ANJALEE KHEMLANI: So as you can hear, they're sending this up to really talk about that, the FDA's authority, and saying that any argument that they are just safe from, I guess, being criticized or being analyzed is off the table there.

- But so what is at stake here, and what is the financial impact we can expect from where this stands? You want to take it?

ALEXIS KEENAN: Sure, yeah, so I think that there's a lot of parties involved here, right? You have first, thinking about patients, those who want to use the drug, they could have financial consequences of having to travel in order to obtain this medication if it is more limited. Then you have the doctors and the medical organizations arguing here, doctors are saying that their malpractice insurance goes up when they have to treat these types of patients. Also the organizations in this case, they're saying that their resources are being diverted away because they are having to spend money on this type of care when they'd rather spend it elsewhere.

And then, of course, you have the pharmaceutical corporations. You have Danco here, the manufacturer, they're saying in court yesterday that this case is an existential threat to their entire business. But then on the other hand, Danco has also given us a statement this morning. They're telling Yahoo Finance, we do not want to prejudge the ruling that will come from yesterday's hearing, but the ruling could potentially be disadvantaged-- disadvantageous, that is, to Danco's financial position. So dialing it back a bit there, but certainly, it would have consequences on them.

- Yeah, and I mean, I think why the outcry is happening right now, too, is, you put it in the context of this is the biggest legal challenge that we've seen since Roe v. Wade. So it just-- it's hard not to like really focus in and see this as a big issue because we saw what happened there. And you never thought you were going to see that happen, you know?

ALEXIS KEENAN: That's right. That's right. And one of the judges did speak to that, saying that this is a very big issue. So the justices-- or the judges, I should say, are certainly aware. But this is a conservative group, panel. This will be a three-judge panel deciding this case. And I think the expectation is that no matter what happens, that the Supreme Court will then see this matter on their desk as well.

- Well, we will certainly continue to follow this. Our thanks to Anjalee and Alexis. Thank you so much for that.