The U.S. Court of Appeals for the 5th Circuit in New Orleans ruled Aug. 16 to restrict access to an abortion pill nationwide, finding that the government may not have followed its own rules when it loosened regulations on the drug. This ruling will not take effect unless the Supreme Court weighs in, meaning the drug will remain on the market for now.
A coalition of pro-life opponents of mifepristone, the first of two drugs used in a chemical abortion, filed suit in an effort to revoke the U.S. Food and Drug Administration's approval of the abortion pill, arguing the government violated its own safety standards when it first approved the drug in 2000. However, proponents argue mifepristone poses statistically little risk to women using it for abortion early in pregnancy, and claim the drug is being singled out for political reasons.
The FDA in 2016 and 2023 expanded the availability of the drug beyond the 2000 standard, increasing the gestational limit on the drug from seven to 10 weeks, and making the drug available via telemedicine.
The appeals court's ruling -- if implemented by the Supreme Court -- would roll back those expansions to their original limits.
"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," Judge Jennifer Walker Elrod wrote in the court's ruling. "It failed to consider the cumulative effect of removing several important safeguards at the same time."
Erin Hawley, senior counsel at Alliance Defending Freedom and vice president of the ADF Center for Life and Regulatory Practice, told reporters on an Aug. 16 press call that "the district rightly required the FDA to do its job and to restore crucial safeguards for women and girls, including ending illegal mail-order abortions."
"The FDA will finally be made to account for the damage it has caused and help countless women and the rule of law by unlawfully removing almost every meaningful safeguard from the chemical abortions drug regimen," added Hawley, who also is the wife of Sen. Josh Hawley, R-Mo.
In a statement attributed to drugmaker GenBioPro, which manufactures generic mifepristone tablets, the company said that "we remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication as well as attempts to undermine the US Food and Drug Administration's regulatory authority."
"We will continue to use our company's legal and regulatory tools to ensure access to mifepristone, which is essential to the health of many in the United States," the statement said.
Jeanne Mancini, president of the March for Life, said in a statement the group "is encouraged by the 5th Circuit's acknowledgment of the FDA's reckless decision to lift critical safeguards related to the administration of powerful drugs used in chemical abortion."
"Most Americans oppose (63%) mail-order abortion which lacks any sort of meaningful medical oversight and places women in danger of serious, life threatening complications, and ends the lives of unborn children," she said. "The FDA has a solemn duty to prioritize health and safety over politics and should be held accountable for failing to do so."
The Catholic Church teaches that all human life is sacred and must be respected from conception to natural death and as such opposes direct abortion as an act of violence that takes the life of the unborn child.
Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America, said in a statement that mifepristone "remains FDA-approved and available in many states across the country, including via telehealth."
"But the 5th Circuit's opinion makes it clear that mifepristone's approval is very much still at risk, as is the FDA's independence," McGill Johnson said. "Pregnant people should be the ones who make decisions about their own health care, and medical professionals should be the ones who make evidence-based decisions about the safety of medications -- not judges. The Supreme Court should reject this clearly baseless and political attempt to interfere with our ability to get health care."
A statement from the American Association of Pro-Life OB/GYNS, one of the groups behind the challenge to the drug, called the ruling "a victory for our patients."
"Over the past two decades, the FDA has repeatedly removed necessary safeguards on the chemical abortion drugs mifepristone and misoprostol," the statement said. "These deregulations have placed women and girls at greater risk of life-threatening complications, as well as coerced abortion by abusers and traffickers."
"Today's ruling by the Fifth Circuit Court of Appeals reinstating these basic safeguards and stopping the dangerous practice of mail-order abortions is a first step towards reprioritizing women's health over the interests of the abortion industry and its allies within our profession," it continued. "As physicians, we will continue to fight for all our patients to be able to receive the best fully informed and evidence-based healthcare possible."
Even if mifepristone is pulled from shelves, another drug used in combination for chemical abortions, called misoprostol, would still be available. Misoprostol is sometimes prescribed by doctors for early miscarriage, and the FDA has not approved the drug for inducing an abortion by itself.
In January, the FDA eased restrictions on the sale of mifepristone, permitting its sale at retail pharmacies for the first time. The decision followed the U.S. Supreme Court's Dobbs decision last year that struck down its previous 1973 Roe v. Wade decision, after which states moved to restrict or broaden abortion access.
The FDA states on its website that the drug's approval was "based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use."
On its website as of Aug. 17, the FDA states that mifepristone "is safe when used as indicated and directed" through 10 weeks gestation. The agency's adverse reaction guidelines for the drug state that "serious and sometimes fatal infections and bleeding occur very rarely."
But opponents of mifepristone say those risks are more common and more dangerous than proponents of the drug say.
