JEFFERSON CITY — Three states have filed an amended complaint in a 2022 lawsuit against the U.S. Food and Drug Administration, accusing the agency of endangering women’s health by removing key safety protocols for abortion medications.
The states — Missouri, Kansas and Idaho — argue that the FDA’s decisions over the past decade have allowed dangerous abortion drugs to be distributed online and via mail, increasing the risks to women, particularly in states with restrictive abortion laws, according to the Oct. 11 amended complaint filed in U.S. District Court for the Northern District of Texas.
The plaintiffs allege that the FDA, which is tasked with ensuring the safety and welfare of Americans, failed in its duty by rolling back safety standards for the use of mifepristone, a common abortion drug.
According to the FDA's own data, approximately one in 25 women who take abortion drugs may require emergency care, the lawsuit states.
The lawsuit claims that by permitting these drugs to be mailed and dispensed without a doctor’s examination or follow-up care, the FDA is responsible for women suffering from serious complications such as severe bleeding, ruptured ectopic pregnancies and life-threatening infections.
In the court filing, the states point to several significant policy changes made by the FDA, beginning in 2016.
That year, the FDA extended the permissible use of mifepristone from seven to ten weeks of pregnancy, reduced the number of required in-person doctor visits from three to one and allowed non-physicians to prescribe the drug.
The lawsuit argues that these changes increased the risk to women, as the likelihood of complications rises as pregnancy progresses. The states sldo argue that the removal of required follow-up visits further exacerbates the risks.
The lawsuit criticizes the FDA for eliminating a requirement that abortion providers report non-fatal complications, a safeguard that was based on earlier safety protocols that have since been removed.
This, the plaintiffs argue, leaves women vulnerable to adverse outcomes that go untracked and unaddressed.
The legal challenge points to actions taken by the FDA in 2021 and 2023, under the Biden administration, which allowed the drugs to be dispensed by mail and expanded their availability through retail pharmacies.
The plaintiffs claim that these decisions violated federal laws prohibiting the distribution of abortion drugs by mail and that the FDA failed to consider the cumulative effects of removing multiple safeguards simultaneously.
The states also argue that the FDA violated the Pediatric Research and Equity Act by ignoring the potential impact of these changes on adolescent girls, who were not adequately assessed for the safety and effectiveness of the revised drug regimen.
The lawsuit calls for the court to reverse the FDA’s actions and reinstate the original safety standards, which included mandatory in-person visits and stricter controls on who could prescribe and administer the drugs.
The plaintiffs claim that the FDA’s actions were reckless and unlawful, and they urge the court to protect women’s health by vacating the recent regulatory changes.
The attorneys general of Kansas, Missouri and Idaho — Missouri's Andrew Bailey, Kansas' Kris Kobach and Idaho's Raul Labrador — are representing the states.
The Supreme Court previously dismissed a similar lawsuit from doctors who lacked standing, but the states argue they can bring the case due to their interest in protecting citizens, particularly concerning residents receiving abortion pills from out of state.
Despite studies showing mifepristone is safe and effective, the states claim it is dangerous and also argue that mailing abortion pills is illegal under the dormant Comstock Act.
The states want the court to roll back the FDA’s 2016 and 2021 updates, which would restrict access to the drug to in-person prescriptions, limit its use to seven weeks of pregnancy, and prohibit mailing it.
Bailey declined to comment. The FDA has yet to comment.
U.S. District Court for the Northern District of Texas, Amarillo Division case number: 2:22-cv-00223