No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule

Abstract

This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible. It gives a summary of the history of the enactment of this regulation and outlines its structure and major features. Next, the regulation is analyzed in light of statutory authority, ethics, and practicality. Finally the approval of pyridostigmine bromide under the Animal Efficacy Rule is evaluated in light of these concerns to determine whether the rule is acting as intended, illustrating remaining problems in implementation. The article concludes that while the Animal Efficacy Rule meets ethical requirements and is capable of being implemented given careful supervision, the FDA does not have statutory authority to make such regulation and thus a legislative solution is preferable.