Federal Judge Allows 3 States to Proceed With Legal Challenge to Abortion Pill Regulations

A Texas judge has allowed three states to continue their legal challenge against FDA policies on the abortion pill mifepristone.

A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kan., on, Oct. 12, 2022. Charlie Riedel/AP Photo

A federal judge in Texas has ruled that three Republican-led states can proceed with their legal challenge to federal regulations governing the abortion pill mifepristone, potentially shaping the future of access to chemical abortions nationwide.

The decision, issued by U.S. District Judge Matthew Kacsmaryk on Jan. 16, grants Missouri, Kansas, and Idaho permission to file a new, amended complaint against the U.S. Food and Drug Administration (FDA). The FDA previously argued in court filings that the states lacked standing to pursue their claims.

The states’ legal challenge centers on the FDA’s approval and regulation of mifepristone, which they allege violates federal law and poses health risks. The FDA has repeatedly defended its regulations with respect to the abortion pill, including in a court filing that characterized the plaintiffs’ allegations of harm as “speculative” and their arguments as “without merit.”

The three states had brought their initial lawsuit against the FDA by intervening in a case started by a coalition of pro-life doctors and medical groups, led by the Alliance for Hippocratic Medicine. The coalition dropped the lawsuit after the U.S. Supreme Court ruled in June 2024 that the plaintiffs lacked standing. Missouri, Kansas, and Idaho pressed forward with their bid to restrict access to the abortion drug nationwide, with the judge’s Jan. 16 decision clearing the way for their legal challenge to continue.

In his order, the judge focused on the standards set by Federal Rule of Civil Procedure 15(a)(2), which he noted encourages courts to “freely give leave when justice so requires.” Kacsmaryk further noted that the presumption is that a court should grant permission—in this case for the three states to file an amended complaint—unless there is “substantial reason” to deny it. In deciding to allow the states to continue their legal battle, the judge noted that the FDA’s motion to dismiss was made on the grounds of standing but did not address issues of undue delay, bad faith, or undue prejudice.

The three states filed their amended complaint immediately after Kacsmaryk issued his order. The new filing broadens the states’ arguments by introducing new evidence, media references, and expanded arguments to highlight the alleged impacts of FDA policies on state regulations, based on developments that have occurred since their original complaint was filed in January 2024.

Specifically, the amended complaint alleges that FDA policies have enabled organizations in states with less restrictive abortion laws to distribute mifepristone to individuals in states such as Missouri, Kansas, and Idaho, where abortion is more heavily regulated.

The states cite an August 2024 Wall Street Journal report detailing “pill-packing parties,” in which volunteers assemble shipments of abortion pills for women in states with stricter abortion laws. According to the complaint, these activities illustrate how FDA-approved mail-order and telehealth systems undermine the ability of states to enforce their own abortion regulations.

The amended complaint also focuses on the FDA’s decision to extend the timeframe for using mifepristone from seven weeks to 10 weeks of pregnancy and to relax Risk Evaluation and Mitigation Strategies for the abortion drug. These policy changes, the states argue, increase the potential for complications and strain health care systems, as more patients may require emergency care due to adverse reactions.

“Women face severe bleeding, ruptured ectopic pregnancies, and lifethreatening infections because the FDA recklessly removed in-person safety standards that it once provided,” the amended complaint states.

Missouri, Kansas, and Idaho further contend that the FDA’s actions amount to federal overreach, conflicting with their state sovereignty. They argue that these policies create an “FDA-approved pipeline” for circumventing local laws, allowing out-of-state actors to facilitate abortions in ways that run afoul of state regulations.

“The FDA has acted unlawfully,” the three states allege. “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.”

If the court ultimately rules in favor of the states, the decision could have far-reaching consequences, potentially curbing federal agencies’ powers when they conflict with state laws.

The Epoch Times reached out to the FDA for comment but did not receive a response by publication time.