The legal battle over mifepristone raises concerns in the the pharmacetical industry : NPR

NPR's Michel Martin speaks with Harvard Medical School's Ameet Sarpatwari about the legal battle over mifepristone and how it might affect the drug market in the U.S. and beyond.

MICHEL MARTIN, HOST:

As we've been following the legal battle over the abortion pill mifepristone, we've heard from activists and political leaders with different perspectives on abortion per se. But now we're starting to hear from people in the pharmaceutical industry. Hundreds of executives and investors recently issued an open letter decrying the Texas federal judge's order removing FDA approval from the drug. To hear more about these concerns, we called Ameet Sarpatwari, the assistant director of the program on regulation, therapeutics and law at Harvard Medical School. Good morning.

AMEET SARPATWARI: Good morning.

MARTIN: So what are the concerns you're hearing from the industry about this effort to remove the FDA's approval of mifepristone? And do you share them?

SARPATWARI: So I think that the industry is very concerned about the implications of this ruling because it effectively inserts the judiciary into the drug approval process. And this is a drug that's been on the market and has been safely and effectively used for over 23 years. Industry members are wondering, well, if a judge can do that, what else can't a judge, perhaps with an ax to grind, do?

And so you have executives at over more than 500 pharmaceutical companies calling out the judge for having no scientific training, fundamentally undermining the bipartisan authority granted by Congress to the FDA. You've got another trade organization, BIO, calling out the ruling, saying that the court has badly misapplied governing drug approval laws. And you also have the trade organization PhRMA referring and reinforcing the importance of the FDA as the gold standard for determining whether a drug is safe and effective. And I do share all these concerns. The question is, really, what would be off the table from relitigating?

MARTIN: Can I just jump in here and just ask - you know, one can make an argument that medical care in the United States is already a legal and political issue if you consider which procedures are covered, how care is paid for, what kinds of patient concerns are prioritized. There's always been lobbying and public pressure, you know, applied to different aspects of medical care. How is this different?

SARPATWARI: This is different because it's upstream, and this concerns the regulation of medical product, not so much the practice of medicine. And this is the first time that we've seen a judge take a drug off the market without the backing of FDA or the manufacturer itself. And so the worry here is that even before we get to the downstream sort of political and coverage decisions that you're talking about, we've already taken the drug off the market.

MARTIN: And before we let you go, as briefly as you can, what is next for the industry? Do you envision them taking more aggressive steps here? What might they do?

SARPATWARI: So to ensure stability and certainty of the pharmaceutical market, I think that all cards are on the table in terms of what industry may do. You definitely see them voicing their opinions as this case goes up on appeal. I think behind the scenes, too, you will see aggressive lobbying of Congress. And I think it's important to recognize how powerful this industry is. And it's my hope, and I think the hope of many others, that they will be quite aggressive in terms of trying to preserve the integrity of the FDA approval process.

MARTIN: That's Ameet Sarpatwari of Harvard Medical School. Thank you so much for joining us.

SARPATWARI: It's been a pleasure. Thank you.

(SOUNDBITE OF POPPY ACKROYD'S "THE CALM BEFORE")

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