Mail-order access to abortion pill blocked by U.S. 5th Circuit Court

Mail-order access to mifepristone, a Federal Drug Administration-approved abortion pill, will no longer be available, based on a ruling of the U.S. Court of Appeals for the Fifth Circuit.

Circuit Judge Jennifer Walker Elrod delivered the ruling Wednesday in Alliance for Hippocratic Medicine v. Food & Drug Administration, vacating a district court order in part and affirming in part.

For a three-judge all Republican panel, Elrod wrote, “We conclude that the medical organizations and doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations. Accordingly, that component of the district court’s order must be vacated. This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016.”

Mifeprex, a brand name for mifepristone, has been on the market since 2000.

Conditions for mifepristone’s use changed in 2016 and included an increase in maximum gestational age from 49 to 70 days; allowance of non-physicians to prescribe; removal of required follow-up in-person appointments; elimination of a prescribers’ obligation to report non-fatal adverse events; and changes in the method of administration and the dosage.

However, in 2021, the FDA ended the in-person dispensing requirement, an action that was related to the COVID-19 pandemic. The practice of remote purchases was later made permanent.

Meanwhile, some medical organizations and doctors were litigating any use of mifepristone.

A federal court in the Northern District of Texas granted a preliminary injunction on April 7. The FDA appealed and a Fifth Circuit panel heard oral argument on May 17.

In ruling for the plaintiffs, Elrod’s 63-page opinion said the FDA failed to address several important concerns about whether the drug would be safe for the women who use it.

“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person,” Elrod wrote.

In a separate opinion, Circuit Judge James Ho concurred with ending the post-2016 FDA changes, but dissented because he would have preferred to ban mifepristone altogether.

“Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. None of us are. We all make mistakes. And the FDA has made plenty,” Ho said.

“By the applicant’s own admission, the FDA used an unlawful procedure when it approved mifepristone. And the agency’s later regulations are likewise invalid—both under the APA as the majority outlines, and under the Comstock Act as well. In sum, the regulations are ‘not in accordance with law’ and therefore must be set aside,” Ho wrote.

Reacting to the court’s ruling, the Susan B. Anthony Pro-Life America state policy director, Katie Daniel, said, “The FDA ignored science and its own rules when it rubber-stamped Democrats’ reckless mail-order abortion scheme.

Related: Supreme Court: Abortion pill can remain available, as challenge works through courts

“Under multiple Democrat administrations, the FDA threw out common sense and played political games with people’s lives,” Daniel said. “Mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year.”