By Dave Andrusko
District Judge Robert S. Ballou heard arguments Thursday from lawyers representing abortion clinics in three states– Virginia, Montana, and Kansas—asking him to shield them from further limitations on their use of mifepristone, one half of the two-drug chemical abortion techniques. They are asking the judge to force the FDA to drop several longstanding restrictions on how mifepristone can be prescribed.
“Specifically, providers want the FDA and U.S. Department of Health and Human Services to abandon the set of restrictions known as a Risk Evaluation and Mitigation Strategy (“REMS”), which has applied to mifepristone since it was approved 23 years ago,” according to Whittney Evans. “REMS regulates mifepristone in a similar way to chemotherapy drugs, which providers argue is unnecessary and misleading.”
What the providers ultimately want “is for the federal government to remove the REMS designation entirely,” Evans continued. “In the meantime, they’ve asked District Judge Robert S. Ballou for a preliminary injunction to prevent further restrictions and maintain the status quo.”
In a different case now working its way through the courts, pro-life plaintiffs in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA) expressed a radically different view.
They argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.
In that case, District Judge Matthew Kacsmaryk issued a national injunction on April 8th on the use of mifepristone in chemical abortions. On April 21, the U.S. Supreme Court released a decision that stayed lower court rulings and returned the issue to the 5th Circuit.
The pro-abortion plaintiffs argue that mifepristone has been used safely and effectively for more than two decades. “[By] making mifepristone seem uniquely dangerous, FDA’s continuing restriction of mifepristone stigmatizes medication abortion and contributes to the chaos anti-abortion activists now sow,” according to the lawsuit. “Plaintiffs are continuously facing the weaponization of the REMS by anti-abortion activists around the country.”
Indeed, the Department of Justice and Danco Laboratories (which manufactures mifepristone) went so far as to insist that complication rate for women who take mifepristone is miniscule—less than one percent.
But Dr. Randall O’Bannon, director of Education & Research, has cited studies proving that the percentage is much, much higher. (See here.)
He told me “But the coup de grace is probably just exactly what the Alliance for Hippocratic Medicine attorney Erin Hawley cited — the FDA itself, pointing to Table 2 of the 2023 label itself, which showed ER Visits to be between 2.9%-4.6%.
On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex), accurately anticipating and answering many of the issues that have been raised in coverage of the case.
Meanwhile, in a third case similar to the one just heard by Ballou, a federal judge in Washington state came to a dramatically different conclusion. Judge Thomas O. Rice’s ruling compels the FDA not to do anything that might affect the availability of mifepristone in the 17 states (and the District of Columbia) with Democrat attorneys general who have sued. They argued that too many regulations already exist on the drug.