Next steps in mifepristone court fight: What doctors should know

AMA News Wire

Next steps in mifepristone court fight: What doctors should know

May 4, 2023

As lawsuits involving access to mifepristone wind their way through the courts, a late April order from the U.S. Supreme Court for now maintains access to the drug in the states where abortion remains legal.

But physicians should know that the legal challenge is far from over. And future access to the medication—and other Food and Drug Administration (FDA)-approved medication that individuals seek to challenge in the courts—remains very much in jeopardy.

The AMA, which has jointly filed several amicus briefs supporting access to the drug, will continue to ensure that physicians’ voices are heard in the cases, including Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al.

The AMA has emphasized the safety of mifepristone and stressed the importance of patients have access to this vital medical care. In an amicus brief (PDF), the AMA joined other medical and public health organizations in warning the district court that if it reversed the FDA’s mifepristone approval, it would cause “profound and irreparable harm to patients across the country.”

In an op-ed published in The New York Times, AMA President Jack Resneck, MD, explained how the stakes extend beyond medication abortion.

“In seeking to restrict access to abortion across the United States, the plaintiffs in this case have, intentionally or not, seriously jeopardized our nation’s 85-year-old drug regulatory system,” Dr. Resneck wrote. “We must be cleareyed; upholding any parts of the district court’s dangerous ruling would in all likelihood almost immediately prompt challenges to other longstanding safe and effective FDA-approved drugs that doctors and patients rely on every day.”

The next step in the legal proceedings is currently slated for May 17. That is when the 5th U.S. Circuit Court of Appeals in New Orleans will hear arguments on whether to uphold or reverse the U.S. District Court for the Northern District of Texas’ April 7 decision.

The lawsuit claims that the FDA’s initial approval process for mifepristone and subsequent actions to expand access to the drug were inappropriate and that the agency didn’t protect the health and safety of pregnant patients.

Swift court actions have led up to the upcoming May hearing, creating the potential for confusion among patients and physicians at a time when abortion care is already undergoing tremendous upheaval in the wake of last year’s Supreme Court’s decision last year in the case of Dobbs vs. Jackson Women's Health Organization.

Namely, the FDA and the drug’s manufacturer, Danco Laboratories, appealed the district court’s April 7 decision that called for a nationwide stay of the FDA’s approval to the 5th U.S. Circuit Court of Appeals.

Then on April 12, an order from the 5th U.S. Circuit Court of Appeals stopped the part of the district court’s order that aimed to temporarily block the drug’s approval and would have taken away access to the drug nationwide. However, the appellate court order still blocked changes the FDA made in 2016 and beyond. That meant a generic form of mifepristone may have no longer been approved and that physicians would need to dispense the drug in person, stopping pharmacies or physicians from mailing the drug to patients.

The FDA quickly sought emergency relief from the U.S. Supreme Court, which stayed the district-court decision, thus leaving the status quo in place while the litigation proceeds. The Supreme Court sent the case back to the 5th Circuit, where the parties will now submit additional briefs and the court is scheduled to hear oral arguments May 17.

The AMA has joined an amicus brief filed this week urging the 5th Circuit to “preserve access to mifepristone under the conditions of use established by the FDA. Those conditions—set aside without proper basis by the District Court’s order ... are scientifically sound and supported by decades of evidence, and ensure access to an exceedingly safe and commonly used medication that is necessary to preserve the life and health of countless patients.”

During the initial flurry of appeals, the AMA joined 11 other medical organizations, including the American College of Obstetricians and Gynecologists, in filling an amicus brief (PDF) that urges the 5th U.S. Circuit Court of Appeals “to set aside the unprecedented opinion of the district court and preserve more than two decades of FDA approval and patient access to an exceptionally safe and important drug.”

The brief calls the decision one that is “demonstrably at odds with the facts” and “hostile” to patients. The brief further tells the court that the order from the district judge in Texas was issued without an evidentiary hearing and that it disregards the “overwhelming body of evidence” that shows mifepristone is safe.

“The decision is rife with medically inappropriate assumptions and terminology,” the brief explains. “It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.”

Meanwhile, attorneys general in 17 states and the District of Columbia in February filed a lawsuit (PDF) in the U.S. District Court for the Eastern District of Washington that seeks to make mifepristone easier to access by challenging some FDA restrictions on the medication.

Less than an hour after the district court ruling in Texas April 7, a federal judge in Washington state ruled the FDA could not restrict access of mifepristone in the jurisdictions that were part of the lawsuit in his court.

The conflicting rulings from the district courts in Texas and Washington could raise the likelihood that the matter will return to the U.S. Supreme Court. Often, the nation’s highest court is likelier to weigh in on cases when rulings at the circuit court level are at odds with one another. At the time of this publication, the Washington judge’s ruling had not been appealed to the 9th U.S. Circuit Court of Appeals.