< How an abortion pill ruling could threaten the FDA's regulatory authority

MICHEL MARTIN, HOST:

The Justice Department is asking an appeals court to put on hold a ruling from a federal judge in Texas that would halt the FDA's approval of mifepristone. That's a drug that's widely used for abortion care. At the same time, the DOJ is asking a federal judge in Washington state to clarify how the Texas ruling affects his order, which prohibits the FDA from limiting access to the drug. As you might imagine, these contradictory rulings are raising questions about the FDA's authority over medications. Meanwhile, some states are stockpiling the pills, like Massachusetts. Here's Governor Maura Healey.

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MAURA HEALEY: At my request, the University of Massachusetts Amherst agreed to purchase approximately 15,000 doses of mifepristone.

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HEALEY: That's enough - that's sufficient to ensure coverage for well over a year.

MARTIN: We've called Holly Fernandez Lynch to help us understand where we are in this very confusing, very consequential legal battle over abortion pills and the FDA's powers. She's a lawyer by training and an assistant professor of medical ethics and law at the University of Pennsylvania, where she has appointments at the medical school and the law school. Good morning, Professor Fernandez Lynch. Thanks so much for joining us.

First to the latest developments - the pharmaceutical industry leaders have issued a letter slamming the Texas ruling which was issued Friday night. They argue it undermines the "bipartisan authority granted by Congress" - that's a quote - to the FDA to approve and regulate medications. First, I want to ask what you make of this whole issue, and, secondly, has something like this ever happened before, where a judge inserted himself or herself into an administrative or regulatory process like this?

HOLLY FERNANDEZ LYNCH: Great. Well, let me take your second question first because this is truly an unprecedented decision. When the pharmaceutical industry develops their products, they do clinical trials. They evaluate the safety and effectiveness of their drugs, and they submit a massive dossier of data to FDA. And they rely on FDA as scientific experts, experts in regulations and the authority that Congress has granted to the agency to determine which products are allowed to be put on the market in the United States.

And what has happened in this case from the Northern District of Texas is that we have a single federal judge who has inserted himself, standing in for the agency, to say FDA should have never approved mifepristone because they did not have adequate data to determine that it was safe. In fact, we have over a hundred studies over 30 years examining the safety of this product. It is absolutely safe, and FDA has evaluated the product multiple times over the years.

MARTIN: And so mifepristone, as you just pointed out, got FDA approval nearly a quarter of a century ago. We mentioned that it is used to end pregnancy, but it's also commonly used to help manage miscarriages. Did the complainants here raise any new concerns about the drug?

FERNANDEZ LYNCH: They really didn't. They, frankly, cherry-picked a couple of studies out of the hundred that I mentioned. There's no new evidence that was presented to the court that would change FDA's determination about whether this product meets the statutory standard for approval. What changed in this case was that, ultimately, the litigants were able to get their arguments in front of a federal judge.

MARTIN: If this - judges get to make calls on drug approvals, how would the pharmaceutical industry respond to that?

FERNANDEZ LYNCH: You know, as I as I mentioned - right? - what the industry does is they devote their resources to identifying which products are going to be safe and effective, to evaluating those products, to submitting that information to FDA and expecting that we are going to hear from the government with a unified voice - from FDA - that this product is legally available for marketing or not.

Now, what may happen, if this decision is allowed to stand, is that industry is going to think, hmm, maybe we shouldn't spend our resources on drugs that might be controversial - that might cause, you know, people to take us to court to say that FDA was wrong in approving this drug. Maybe we should just stick to things that aren't - you know, aren't going to ruffle any feathers. And that's going to be damaging for patients who rely on vaccines, for example - we know that's a really controversial area of FDA regulation - or perhaps gender-affirming care.

MARTIN: One more question - some Democrats are calling on the Biden administration to ignore the Texas ruling. The White House says that would set a dangerous precedent. What's your take on that, as briefly as you can.

FERNANDEZ LYNCH: I agree - it is a dangerous precedent for one branch of the government to ignore another. There are a number of steps that the Biden administration can take and is taking to follow, you know, the legal trajectory here, which is to appeal to the 5th Circuit, appeal to the Supreme Court if necessary. And ultimately, it would get, you know, a Supreme Court decision. FDA has the authority to exercise enforcement discretion in deciding whether to go after any company.

MARTIN: That's Holly Fernandez Lynch, assistant professor of medical ethics and health policy at the University of Pennsylvania. Professor, thanks so much.

FERNANDEZ LYNCH: Thank you.

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