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.” Courtesy photo

 

AMARILLO, TX (MPG) - Missouri, Kansas, and Idaho have filed a lawsuit in federal court that renews a legal challenge against the U.S. Food and Drug Administration (FDA) over relaxing safety regulations and illegally allowing widespread access to the dangerous abortion pill Mifepristone. In June 2024, the U.S. Supreme Court dismissed a case from a group of pro-life doctors against the FDA’s abortion pill deregulation after the High Court determined the doctors did not have legal standing to sue. The new amended lawsuit, which could end up back at the Supreme Court in the future, asserts that the three states have legal standing because the relaxed restrictions undermine state pro-life laws protecting women, girls, and unborn children by putting lives and health at risk.

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 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.

From 2016 to 2021, the FDA deregulated Mifepristone so it could be used through the 10th week of pregnancy, rather than only through the 7th week; allowed healthcare providers who are not physicians to prescribe the drugs; relaxed adverse reporting requirements; and allowed the drug to be prescribed online through telehealth appointments and sent through the mail defying the federal Comstock Act that prohibits sending abortion through the mail. The FDA made these changes despite the drug’s questionable safety record.

The states allege these actions not only violate the safety requirements of the Pediatric Research and Equity Act and the Federal Food, Drug, and Cosmetic Act due to the potential harms for pregnant women and girls, as well as the Comstock Act, they also disregard state abortion laws and “enable and encourage” people to do what state law expressly prohibits.

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] FDA permitted and sometimes even encouraged these illegal activities. But a federal agency cannot authorize unlawful actions,” wrote Missouri, Kansas, and Idaho. “In rolling back safeguard after safeguard, the FDA has turned a blind eye to the known harms of abortion drugs to the detriment of women and girls.”  

The states are asking U.S. District Judge Matthew Kacsmaryk, who presided over the original abortion pill case, to impose 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 also gives Judge Kacsmaryk the option for a permanent injunction to render all of the FDA’s deregulation actions for Mifepristone as unlawful.

The three states noted in the lawsuit, “The FDA’s actions thus ‘intrude on state governmental functions’ and hobble States’ efforts to protect health and safety.”

In April 2023, Judge Kacsmaryk found 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.

Mifepristone is part of a two-drug regimen that starves an unborn baby to death, while the second drug, Misoprostol, expels the baby from the womb. Mifepristone is manufactured under the label Mifeprex and comes with a “black box warning,” which is the FDA’s strongest warning for drugs with major risks. Before the FDA removed the reporting requirements for adverse events, 26 deaths and 4,207 adverse events associated with Mifepristone had been reported.

Mifeprex’s medication guide advises abortive mothers to expect cramping, vaginal bleeding, and that they may potentially see blood clots and tissue. The guide even states that 2.9 to 4.6 percent of women who take the drug will end up in the emergency room.