Judge Rules Abortion Pill Challenge Against FDA Can Go Forward

The decision by U.S. District Judge Matthew Kacsmaryk allows the states to transition a previous lawsuit from a group of pro-life doctors that the U.S. Supreme Court dismissedafter it determined the doctors did not have legal standing to sue. The new lawsuit, which continues to be amended, could end up back at the Supreme Court in the future. The states assert they have the legal standing to sue the FDA because its relaxed restrictions involving a dangerous drug like Mifepristone puts lives and health at risk and undermines state pro-life laws protecting women, girls, and unborn children.

Specifically, the states are challenging the FDA’s decisions to allow the drug to be prescribed over telehealth without an in-person visit, as well as be delivered by mail and its approval of a generic version of the drug.

In April 2023, Judge Kacsmaryk presided over the original abortion pill case from the pro-life doctors and determined that the FDA shouldn’t have approved Mifepristone for public use in 2000 and voided its approval. He noted the agency approved the abortion pill under political pressure, its safety studies were improperly conducted, and that the FDA’s regulatory decisions allowing them to be prescribed via telemedicine, sent by mail, and dispensed at retail pharmacies were unlawful. While the Fifth Circuit Court of Appeals largely upheld his ruling, the Supreme Court vacated the injunction allowing all of the FDA’s deregulation actions to stay in effect.

The states are now asking Judge Kacsmaryk to reimpose a preliminary injunction that reinstates Mifepristone’s regulations that were in place prior to 2016. The lawsuit asks the judge to:

• restore follow up visits with a physician on Days 3 and 14 after taking abortion drugs.
• restore the maximum gestational age to seven weeks from 10 weeks.
• restore the requirement that prescribers be physicians.
• restore the requirement that physicians report all serious and non-fatal adverse events to the FDA.
• restore the in-person dispensing requirement.

The lawsuit contends that the FDA “has the statutory responsibility to protect the health, safety, and welfare of all Americans by putting commonsense safeguards on high-risk drugs.” The FDA made regulatory changes surrounding Mifepristone despite the drug’s questionable safety record. The states note that the FDA’s own warning label for abortion drugs say about one in 25 women taking the drugs “will” visit the emergency room. 

The states allege that the FDA has “disregarded” health and safety by removing Mifepristone’s safety standards which has created conditions where women and girls can face severe and life-threatening complications due to easy access to the drugs through the mail and little to no medical oversight while taking them – conditions that bypass state pro-life protections and send women and girls to emergency rooms.

According to the three states, the FDA lacked legal authority to make these decisions and acted “arbitrarily and capriciously,” committed an “an abuse of discretion,” and acted “otherwise not in accordance with law.”

The lawsuit also gives Judge Kacsmaryk the option for a permanent injunction to render all of the FDA’s deregulation actions for Mifepristone as unlawful.

Liberty Counsel Founder and Chairman Mat Staver said, “The FDA must be held accountable for its dangerous and unlawful actions. The FDA should no longer be allowed to circumvent safety laws to allow a eugenic drug to destroy innocent children and harm women. Abortion drugs have never been safe and harm women and kill children.”