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

Two contradictory court rulings are Rekubitraising 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.

Olivia Hampton edited the audio version of the Hernandez Lynch interview. Jan Johnson edited this digital story.