Dueling rulings lead to confusion over abortion drug access : NPR

SCOTT DETROW, HOST:

** Last night, a federal judge in Texas suspended the Food and Drug Administration’s approval of a widely used abortion pill. That FDA approval came more than 20 years ago for a pill called mifepristone, one of two pills used in most medication abortions. In another ruling issued last night, another federal judge, this one in Washington state, issued a conflicting order demanding that the FDA keep the abortion pill on the market. To help sort some of this out, we have turned to NPR’s pharmaceuticals correspondent, Sydney Lupkin. Sydney, thanks for joining us.

SYDNEY LUPKIN, BYLINE: Hi, Scott.

DETROW: So there’s a lot to sort through. The first thing I’m wondering is, has a judge ever told the FDA before to take a drug’s approval away?

LUPKIN: You know, this is really unprecedented. So in general, the courts are supposed to defer to the expertise of the agencies. So you’ve got the FDA chock-full of scientists and doctors, and then you’ve got a judge without a medical or scientific background. So the FDA has been sued before, but usually, if it loses, the judge just says, you know, hey, redo this – you know, nothing like what just happened.

So in this case, the Texas judge sided with the antiabortion group and said the FDA never should have approved mifepristone 23 years ago. And by the way, the judge’s ruling never includes the word fetus. The judge in Texas only uses the words like unborn child or unborn human. Allison Whelan, a professor at Georgia State University College of Law, talked to me about that. And here’s how she reacted to the judge’s ruling.

ALLISON WHELAN: I had a very similar, if not even more visceral reaction to it than when I even read Dobbs just simply because of the language used. It is rife with just study after study that have been discredited.

LUPKIN: So Dobbs is, of course, the ruling last summer that overturned Roe v. Wade after it kept abortion legal for almost 50 years.

DETROW: OK, so what happens now?

LUPKIN: So the Texas ruling says that in seven days, the FDA will need to suspend its approval of mifepristone. So at least for the next week, it’s still on the market. It’s still approved, should still be available. But the Biden administration has appealed and will seek a stay to keep it on the market while this all plays out. Meanwhile, as you already said, another judge, presiding over a separate case in Washington state ruled, last night that the FDA can’t change anything about its approval and needs to keep mifepristone on the market. So the conflicting opinions in two different circuits is pretty much a fast track to the Supreme Court.

DETROW: All right. So let’s look ahead. Say the courts ultimately do decide that the FDA does have to suspend its approval of mifepristone. Is there anything the FDA can do?

LUPKIN: Well, yeah. So it’s the FDA’s job to take enforcement action against companies trying to peddle unapproved drug products. And in this case, the agency could choose not to. In other words, it could use what’s called enforcement discretion and just not go after anyone making or selling mifepristone. Some say that would be a crazy move for the FDA because it sets up a big conflict between the courts and the agency. And others say it’s not so different from, like, a police officer saying that they’re not going to go after every driver who’s speeding because, you know, they have limited resources.

DETROW: Well, that leads to the question that if this ruling sticks, what does that mean for the drug industry in general?

LUPKIN: So it could have a really chilling effect on both the FDA and the drug industry. So if the courts can just reverse an FDA approval despite its review of, you know, evidence that a product is safe and effective, then what other approvals might it reverse? The FDA doesn’t have the resources to get sued a lot. That’s time. That’s taxpayer dollars. So it might think twice about approving drugs that might get politicized. Think medications for HIV, gender-reaffirming care, maybe vaccines. And then backing up further, the drug industry might not want to do the time-consuming and expensive work of studying and seeking approval for these drugs because a single judge could wipe out that approval.

DETROW: That was NPR pharmaceuticals correspondent Sydney Lupkin. Thank you, Sydney.

LUPKIN: You bet.

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