3 states pick up abortion pill lawsuit against Food and Drug Administration

Washington, D.C. Newsroom, Oct 21, 2024 / 17:50 pm

Three states have picked up a lawsuit previously dismissed by the U.S. Supreme Court earlier this year against the Food and Drug Administration (FDA) over its removal of safety restrictions on abortion drugs. 

In June 2023, the Supreme Court issued a unanimous decision saying the group of pro-life doctors and organizations who filed the original case lacked standing as they could not show they had been harmed by the abortion drug mifepristone’s widespread availability. 

The states of Missouri, Kansas, and Idaho argue in the new lawsuit, filed in the same Texas federal court as the original case, that “women should have the in-person care of a doctor when taking high-risk drugs.”

Since the FDA rolled back its regulations, the states wrote in the filing, abortion drugs have been “flooding states like Missouri and Idaho [where abortion is otherwise regulated] and sending women in these states to the emergency room.”

The plaintiffs describe the FDA’s move to deregulate the drug as “reckless,” noting that the FDA’s own label estimates that about 1 in 25 women who take mifepristone “will visit the emergency room.” Though side effects of the drug include severe bleeding, life-threatening infections, and ruptured ectopic pregnancies, abortion providers are no longer required to report nonfatal complications.

“This elimination was based on past data collected under the originally approved safety standards, not the new deregulated regime,” the states pointed out, calling the deregulation “unreasonable.”

The original FDA requirements for the drug upon its approval in 2000 limited use to 49 days of pregnancy, required three in-person visits, and could only be administered by certified health care providers at a clinic or health care center. In 2016, the gestational limit was extended to 70 days and the number of in-person consultations reduced to a singular visit.

During the COVID-19 pandemic in 2020, the FDA dropped its consultation requirement altogether and further authorized all certified health care professionals to be able to distribute the drug. Telehealth providers were initially given the temporary ability to distribute the drug via mail that same year. The Biden administration eventually solidified the practice as a norm in 2023. 

Although most of the country requires parental consent for the drug to be prescribed, 18 states — including California, Colorado, Maryland, and Illinois — do not require parental consent for minors to access mifepristone. 

The states also claim in the filing that the FDA “ignored the potential impacts that the removal of commonsense safeguards would have on adolescent girls” and that the administration purposefully categorized pregnancy as a “disease” to avoid having to complete otherwise necessary safety assessments among pediatric patients to approve the deregulations. 

The new filing calls for the drug to be prohibited among patients under the age of 18. 

“The FDA has acted unlawfully,” the states concluded in the amended complaint. “Now, the state plaintiffs ask the court to protect women by holding unlawful, staying the effective date of, setting aside, and vacating the FDA’s actions to eviscerate crucial safeguards for those who undergo this dangerous drug regimen.”