The Fifth Circuit Court of Appeals concluded on Wednesday that the abortion pill mifepristone should remain on the market but that the U.S. Food and Drug Administration went too far when it relaxed restrictions on the drug in 2016 and made the pills available via mail in 2021.

But the 96-page ruling by the three-judge Fifth Circuit panel will likely not have any immediate practical effect because of a Supreme Court decision from earlier this year — a full stay in the legal case — that preserved full access to the pills until all of the appeals are played out.

The Justice Department is expected to appeal Wednesday’s ruling.

Erin Hawley, a lawyer for the conservative legal firm Alliance Defending Freedom, which challenged the FDA’s approval of the two-pill chemical abortion regimen, hailed the ruling as a “significant victory.”

“Today the Fifth Circuit rightly required the FDA to do its job and to restore crucial safeguards for women and girls, including ending illegal mail-order abortion,” Hawley said during a virtual press conference. “The FDA will finally be made to account for the damage it has caused to the health of countless women and the rule of law by unlawfully removing almost every meaningful safeguard from the chemical-abortion drug regimen.”

The FDA’s decisions around approving brand-name Mifeprex in 2000, and then loosening restrictions on the pills in 2016 and 2021, were driven by politics, she said, “without regard to women’s health or the rule of law.”

The Fifth Circuit ruling comes after a lower-court ruling in April suspended the FDA’s original approval of mifepristone in 2000. At the time, U.S. District Judge Matthew Kacsmaryk, a conservative appointed to the Texas court by former president Donald Trump, wrote that the “FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

Less than a week later, a three-judge Fifth Circuit panel voted to restore access to mifepristone, finding that the legal challenge appeared to have been filed after the statute of limitations had expired. But the panel voted 2–1 to put on hold recent changes the FDA has made that made the pills easier to obtain, including limiting necessary doctor visits and allowing the pills to be dispensed through the mail.

Wednesday’s Fifth Circuit ruling appears to mirror the panel’s ruling in April.

The court found that the challenge to the FDA’s 2000 approval of Mifeprex is “likely barred by the statute of limitations.” The court also upheld the FDA’s 2019 approval of a generic version of the mifepristone pills because the plaintiff doctors “have not shown that they are injured by that particular action.”

But the court did affirm the lower court’s ruling that struck down changes the FDA made in 2016 and 2021, including increasing the gestational age for which the drug could be used from seven weeks to ten, reducing the number of office visits required to get the drug from three to one, allowing non-doctors to prescribe the pills, and eliminating the requirement for prescribers to report non-fatal adverse events involving the pills. In 2021, during the Covid-19 pandemic, the FDA allowed the pills to be delivered through the mail.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote. “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.”

While Hawley acknowledged that nothing on the ground had changed because of the Supreme Court stay — the pills will still be available through the mail, at least for the time being, and the FDA’s loosened restrictions from 2016 are still technically in place — she said it still “puts the FDA on notice as well as gives women a reason to maybe think twice about taking mifepristone unsupervised, certainly through the mail.”

The case stems from a lawsuit filed in November by ADF on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors. Their lawsuit claims that the FDA never had the authority to approve the two-pill chemical-abortion regiment when it did so nearly a quarter century ago.

The FDA approved the pills under a portion of the federal code, which allows for expedited approval of potentially dangerous drugs that can be used to treat a “serious or life-threatening illness.” Hawley said that was wrong, because “pregnancy is not a serious or life-threatening illness. It is a natural biological condition.”

Lawyers for the government have argued the drugs are safe and effective and that the FDA’s 2000 approval process for mifepristone was appropriate.

Pro-life organizations applauded the Fifth Circuit ruling on Wednesday. "The FDA ignored science and its own rules when it rubber-stamped Democrats' reckless mail-order abortion scheme,” Katie Daniel, state policy director for Susan B. Anthony Pro-Life America, said in a prepared statement.

"Mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year,” she added. “We won't rest until the FDA and the profit-driven abortion industry are held accountable for the suffering they've inflicted on women and girls, as well as the deaths of countless unborn children."

Chelsey Youman, national director of public policy for the Texas-based Human Coalition called the ruling a “critical win for protecting children in the womb and upholding women's safety.”