FDA Urges Supreme Court to Hear Abortion Pill Access Case

The US Court of Appeals for the Fifth Circuit was wrong when it ruled the FDA’s regulations over abortion drug mifepristone should be rolled back, the agency said in a reply supporting its request that the US Supreme Court hear the case.

In a reply brief filed Tuesday, US Solicitor General Elizabeth Prelogar, on behalf of the Food and Drug Administration, asked the Supreme Court to grant its request for review.

The filing comes after the FDA asked the high court for review in September after the Fifth Circuit found the FDA’s regulations allowing mifepristone to be mailed, taken later in pregnancy, and prescribed by non-physician medical professionals were likely unlawful.

The court ruled that access to the abortion pill should be preserved with some limits.

“The Fifth Circuit’s unprecedented decision contradicts fundamental principles of Article III and administrative law and affirms disruptive nationwide relief,” Prelogar wrote.

“And although respondents emphasize the case’s interlocutory posture, this Court often grants certiorari when lower courts impose broad preliminary relief blocking important federal actions or programs.”

The high court is scheduled to discuss Dec. 8 if it will hear the case.

The challenge against the FDA was brought by the Alliance for Hippocratic Medicine, which alleged the agency did not fully consider safety concerns when it approved the drug or removed some restrictions, among other arguments. The alliance is an association of doctors whose principles include “protecting the vulnerable at the beginning and end of life.”

The alliance’s “refusal to acknowledge—much less defend—the actual basis for the Fifth Circuit’s decision powerfully confirms the need for this Court’s review,” Prelogar wrote.

Danco Laboratories, maker of Mifeprex, the brand version of mifepristone, also filed a reply Tuesday in support its own petition for review. The drugmaker said the Fifth Circuit’s decision directly conflicts with this high court’s precedents on Article III standing and judicial review of agency action.

The amicus briefs filed and groups involved in the case “leave no dispute about whether this case is nationally important,” Danco wrote in the reply.

“It is,” the company said.

The case is All. for Hippocratic Med. v. Food & Drug Administration, No. 23-235, reply 11/21/23.