FDA Cites Precedent in Abortion Pill Case Ahead of Supreme Court Hearing

The Food and Drug Administration is urging the US Supreme Court to reverse a lower court decision that could restrict access to the abortion medication mifepristone. The agency argues that the doctors and groups involved in the lawsuit do not have the right to sue.

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

Central to the government’s appeal is whether the physicians and groups involved in the lawsuit have standing to sue under Article III of the US Constitution. The FDA argues that 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 as a result, they should not be able to continue with the litigation.

The brief stated that 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 were unlawful. The government argues that the panel reached this “unprecedented result through a series of errors that contradict this Court’s precedents and violate black-letter Article III and administrative-law principles.”

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

In its brief, the company argues that the physicians lack standing and also states 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.