The mifepristone ruling may deter the development of new drugs, experts say
ANDREW LIMBONG, HOST:
An appeals court decision could come as soon as tomorrow over the abortion drug mifepristone. Now, the pharmaceutical industry is saying that a decision to limit access to the drug could have effects far beyond abortion. NPR's Becky Sullivan joins us now for more on this. Hey, Becky.
BECKY SULLIVAN, BYLINE: Hello.
LIMBONG: All right. So to start on this, tell us the concerns raised by the pharmaceutical industry.
SULLIVAN: Yeah, you know, so the pharma industry had actually been kind of quiet on this case up until this week. So 'cause now what's changed is that there's this preliminary injunction from a federal judge in Texas - it's set to go into effect this coming Friday - that would essentially undo the FDA approval of this drug. And the industry has started to make it very clear that they think this ruling was bad. So more than 500 pharmaceutical executives, investors and researchers - they signed an open letter earlier this week that criticized the decision. And then just yesterday, some went even further and filed a brief in the case urging the appeals court to side with the DOJ and overrule essentially this lower court injunction. They said in pretty strong terms, you know, it could, quote, "wreak havoc on drug development and approval." It could cause, quote, "widespread harm to patients, providers and the entire pharmaceutical industry." That brief was signed by about 100 executives and 20 pharmaceutical companies, including Pfizer, one of the largest in the U.S., obviously. And today, the biggest industry group, which is called PhRMA, put out a statement saying they have, quote, "serious concerns with any court substituting its opinion for the FDA's expert approval decision-making."
LIMBONG: Yeah, strong words - so why exactly does the industry think this is such a threat?
SULLIVAN: Well, in short, it takes a lot of time and money to develop a drug and get it to market with FDA approval. We're talking years. We're talking hundreds of millions of dollars. And so part of what makes that investment possible for the companies, they say, is that there is, quote, "clarity and predictability in the FDA's review and approval process." It's consistent. They know what to expect. But this decision about this abortion drug throws that up in the air, they say. It's a drug that's been on the market for more than 20 years. It has a very reliable safety record. Yet there's just one lawsuit, one judge, and now it seems that the approval could be revoked. And they call that a seismic shift. So pharmaceutical companies in their brief argued that they might have to run larger and more detailed clinical trials, which could make them more expensive, could force them to change the way they label their drugs or make it difficult or expensive to expand the use of drugs after their original trials, which currently is very common.
LIMBONG: And they say that would be true of all drugs or just abortion medication?
SULLIVAN: They do. Yeah. No, all drugs - so legal experts say this decision could open the door for essentially a new way of challenging drugs of any kind. So this morning, I talked to Allison Whelan. She's a law professor at Georgia State University, and she told me while this might start with abortion, it could basically expand, especially to any politically or socially controversial medical products.
ALLISON WHELAN: Take vaccines - that's a key prime example. This is essentially saying here is a way that you could stop these vaccines that you disagree with, not for safety and efficacy reasons but for other reasons.
SULLIVAN: And so, as she says, that target could be vaccines or it could be, say, preventatives for sexually transmitted diseases, could be gender affirming care for transgender people. And all of these things take time and money for companies to develop and time, of course, for the FDA to approve. And so if those processes get longer and more expensive and can just get thrown out by a judge anyway, companies, I guess, may just decide that it's no longer worth it.
LIMBONG: All right. So what's next on this?
SULLIVAN: Well, this is all happening very fast this week. So the case is now at the Fifth Circuit Court of Appeals. That is traditionally a pretty conservative court. Both sides, a coalition of conservative groups, along with the DOJ, the U.S. government, have now weighed in, and the court is considering it. And so this original preliminary injunction is set to go into effect this coming Friday. The DOJ has asked for the appeals court to respond before then. They've asked for them to do so by noon on Central time tomorrow.
LIMBONG: That was NPR's Becky Sullivan. Becky, thanks so much.
SULLIVAN: You're welcome. Transcript provided by NPR, Copyright NPR.