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Judge rejects petition from abortion providers in three states who sought to block potentially more protective FDA restrictions on access to mifepristone

by | Aug 23, 2023

By Dave Andrusko

District Judge Robert S. Ballou, a federal judge in Virginia, has rejected a petition by abortion clinics in Kansas, Montana, and Virginia, asking the court for a preliminary injunction to block potentially more stringent FDA restrictions on access to mifepristone. Mifepristone is one of two drug that make up chemical abortions—“medication abortions.”

According to Celine Castronuovo, of Bloomberg Law, Judge Robert S. Ballou for the US District Court for the Western District of Virginia wrote “A preliminary injunction preventing the Food and Drug Administration from ‘altering the status quo’ on its regulation of mifepristone as the pill faces multiple legal battles across the country would be ‘an extraordinary remedy.’”

There are clear requirements for a preliminary injunction “that Plaintiffs do not currently meet,” Ballou wrote, “In each state in this action, mifepristone remains available to prescribe, and FDA has made no indication that it intends to limit access to mifepristone. The uncertainty at the heart of Plaintiffs’ preliminary injunction request comes from circumstances unrelated to any party in this case and not because of FDA action or impending action.”

Specifically, the abortion clinics “wanted 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,” Whittney Evans reported.

“What the providers ultimately want,” Evans wrote, “is for the federal government to remove the REMS designation entirely. In the meantime, they asked District Judge Robert S. Ballou for a preliminary injunction to prevent further restrictions and maintain the status quo.”

Judge Ballou declined.

In his opinion, Judge Ballou concluded

Plaintiffs have not clearly established that they will suffer irreparable harm because of FDA’s actions in the absence of preliminary relief. Presently, mifepristone, whether in a generic or name brand form, can be marketed and prescribed by providers and used for the effective and safe termination of a pregnancy. Plaintiffs have offered no evidence that FDA intends to take action to change any of mifepristone’s REMS or to restrict the access of the drug in Virginia, Kansas, or Montana. Indeed, FDA has been enjoined from changing the REMS at this time in 17 states and the District of Columbia by the Washington court. The record contains no evidence that FDA can promulgate regulations that would apply in certain states and not others, that it has ever done so, or that it intends to take such action. Thus, much of Plaintiffs’ allegations of irreparable harm are not rooted in actual and imminent events or actions taken by FDA. …

Finally, the harm Plaintiffs allege could result from the Alliance case is purely speculative. Because of the Supreme Court’s stay in the Alliance case, mifepristone remains available and viable medical option for health care professionals in Virginia, Kansas, and Montana. I agree that the outcome of the Alliance case could have an impact on Plaintiffs, but it is neither necessary nor appropriate to issue a preliminary injunction in anticipation of or because of a ruling from another court.”

Categories: Abortion Pill