FDA Points to Precedent in Abortion Pill Case Before Justices

The Food and Drug Administration is urging the US Supreme Court to undo a lower court decision that could limit access to the abortion medication mifepristone, arguing the doctors and groups behind the litigation have no right to sue.

Docketed Tuesday, the arguments come in the first brief the FDA filed with the court since the justices agreed to hear the case. The agency asked the justices to take the case after the US Court of Appeals for the Fifth Circuit blocked FDA decisions in 2016 and thereafter that expanded access to mifepristone.

Key to the government’s appeal is whether the physicians and groups behind the suit have standing to sue under Article III of the US Constitution. In the FDA’s telling, these groups “do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything,” and therefore they shouldn’t be able to carry on the litigation.

The brief said the lower court suspensions of the FDA’s decisions on the drug “would upend the regulatory regime for mifepristone, with disruptive consequences for FDA, mifepristone’s sponsors, and women who need access to the drug.”

A Fifth Circuit panel found in August 2023 that FDA decisions on mifepristone, like permitting its use later in pregnancy and allowing the drug to be mailed to patients, were unlawful and should be cut down.

The Fifth Circuit reached its “unprecedented result through a series of errors that contradict this Court’s precedents and violate black-letter Article III and administrative-law principles,” the government said.

Danco Laboratories LLC, the drugmaker behind the name-brand mifepristone drug Mifeprex, is challenging the Fifth Circuit decision alongside the government and also filed a brief.

In its brief, the drugmaker argues the physicians lack standing, writing that their “speculative claims of injury to unknown association members based on attenuated chains of unknown third parties’ actions and circumstances satisfy none of the Article III standing requirements.”

Danco also argued that the groups “presented no valid basis to enjoin FDA’s reasonable and reasonably explained decision to modify requirements related to mifepristone’s use in 2016 and 2021.”

“The questions presented are not hard under existing precedent. They do not ask the Court to wade into a politically charged debate around abortion. The same rules govern here that govern any challenge to agency action by any plaintiff. This Court’s precedents therefore make short work of this case,” Danco said.

The case is FDA v. All. for Hippocratic Med., U.S., No. 23-235, brief filed 1/23/24.