Two contradictory court rulings are raising questions not only about the future of the abortion pill mifepristone, but the federal government's authority to approve and regulate drugs in general.
Mifepristone is widely used across the U.S. to end pregnancy in the first 10 weeks of gestation and help manage miscarriages. The Food and Drug Administration (FDA) first approved it in 2000, after it evaluated data and concluded the drug's health benefits outweigh its risks.
More than two decades later, a federal judge in Texas refuted the FDA's approval, issuing an injunction that would suspend its approval nationwide. That pause is set to take effect on Friday, though the Justice Department has appealed to block it.
In Washington state on Friday, a different federal judge issued a separate ruling that prohibits the FDA from pulling the drug from the market.
Judges' decisions heighten uncertainty
Uncertain about the future of mifepristone access, several states began stockpiling doses of the drug, major pharmaceutical companies expressed support for the FDA, and some Democrats and at least one Republican lawmaker urged the Biden administration to ignore the Texas ruling (a suggestion the White House dismissed as a potentially "dangerous precedent").
Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania, calls the Texas ruling "truly an unprecedented decision."
She tells Morning Edition's Michel Martin that pharmaceutical companies that develop new products typically conduct clinical trials, evaluate drugs' safety and effectiveness, and submit a "massive dossier of data" to the FDA, the agency given authority by Congress to determine which products can go to market.
"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," Fernandez Lynch says.
Plaintiffs revive questions, despite safety history
Fernandez Lynch says more than 100 studies over 30 years affirm the safety of mifepristone, which the FDA has evaluated multiple times over the decades (including approving a generic version in 2019).
But in November 2022, months after the Supreme Court overturned the federal abortion protections of Roe v. Wade, a coalition of anti-abortion doctors and groups filed a lawsuit seeking to undo the drug's approval, reviving an earlier attempt that had been denied in 2016.
Fernandez Lynch says the plaintiffs "cherry picked" a couple of those studies to make their argument.
"There was 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," she adds. "What changed in this case was that ultimately the litigants were able to get their arguments in front of a federal judge."
What does it mean for the drug approval process?
Former FDA Commissioner Jane Henney, who led the agency in 2000 when mifepristone was first approved, disputes allegations that its approval was improperly fast-tracked.
"I can assure you that mifepristone was handled in a very proper way. It was given a very thorough review. It was not rushed," she told NPR's Juana Summers in an interview for All Things Considered on Tuesday.
She acknowledges that the mifepristone was approved under a section of the law that provides for an accelerated process, but denies that safety was compromised.
"The approval process, in terms of looking at all the scientific data, all of the clinical data, the data around how this drug was manufactured followed the normal process of how the FDA reviews every product that it has," Henney says.
Fernandez Lynch says if judges can weigh in on drug approvals, the pharmaceutical industry could choose to "stick to things that aren't going to ruffle any feathers."
"What may happen, if this decision is allowed to stand, is that the industry is going to think, 'Hmm, maybe we shouldn't spend our resources on drugs that could be controversial, that might cause people to take us to court to say that FDA was wrong in approving this drug,'" Fernandez Lynch says.
Henney also says the Texas ruling is "disappointing" because it not only sends a "very chaotic" message to people seeking abortion care, but could call into question the validity of the FDA process, what she calls the "gold standard" for the U.S. and the world.
"If that is disrupted, it really causes chaos not just in the marketplace, but chaos for medical providers and patients who need a sound and solid voice of authority to say this has been reviewed, these products are safe and effective," says Henney.
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.
(SOUNDBITE OF ARCHIVED RECORDING)
MAURA HEALEY: At my request, the University of Massachusetts Amherst agreed to purchase approximately 15,000 doses of mifepristone.
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. Transcript provided by NPR, Copyright NPR.