FDA fires back at conservative group's lawsuit over abortion pill approval

In the months since the Supreme Court reversed the landmark Roe vs. Wade decision, the discourse surrounding abortions has reached a fever pitch. Now, after anti-abortion groups asked the courts to reverse the FDA’s 2000 approval of medical termination drug Mifeprex (mifepristone), the agency is pushing back.

In a recent filing in Texas federal court, the FDA said the plaintiffs are challenging its regulatory action “long after the limitations period has expired.” 

Back in November, the Alliance for Hippocratic Medicine filed a complaint arguing the FDA rushed its 2000 approval of the drug. The agency justified the decision by calling pregnancy an “illness” and by saying Mifeprex provided a “meaningful therapeutic benefit” over existing treatments, the plaintiffs argued.

“In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the suit said.

Hitting back, the FDA responded that the suit failed to prove that the plaintiffs are suffering imminent and irreparable harm. Their “speculative assertions of injury,” which were “made months and even decades” after the approval in question, are “unsupported by any evidence," the FDA said.

Further, the action the lawsuit seeks—an overturning of the approval—would cause harm by depriving patients of a safe and effective drug, the FDA’s attorneys at the Department of Justice said in the court filing. It would “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution," they added.

Aside from those arguments, the FDA said an injunction would interfere with its regulatory autonomy provided by Congress.

Medication abortion now accounts for more than half of the abortions in the U.S., according to The New York Times. Using Mifeprex, also known as mifepristone, is cheaper, less invasive and offers more privacy than surgery. But the drug has been at the center of national controversy since last summer's Supreme Court decision.