September 14, 2023

Fifth Circuit FDA Decision Puzzles

Drug & Device Law
Eric L. Alexander

Litigation attorney Eric Alexander wrote a column for the Drug & Device Law Blog about the recent Apter v. HHS case discussing the Fifth Circuit's decision to reverse the dismissal of claims against the Food and Drug Administration (FDA). The court's key finding was the FDA's lack of express authority to discourage off-label use. The court allowed plaintiffs, Texas physicians challenging the FDA's statements on ivermectin use to proceed with ultra vires under the APA, emphasizing the need for FDA to establish a "colorable basis" for its actions. Mr. Alexander discusses the implications of this decision, questioning the FDA's regulatory control over truthful statements by drug and device companies regarding off-label uses and its potential impact on industry practices.

READ: Fifth Circuit FDA Decision Puzzles

Related Insights