Organizational Reputation and Jurisdictional Claims: The Case of the U.S. Food and Drug Administration

Abstract

When do regulatory agencies expand, following the emergence of novel technologies? This article presents a verbal model that suggests that a regulator is most likely to announce that it has statutory authority to regulate a novel technology when its reputation is at stake. This is most likely to occur when (1) new information becomes available to the regulator regarding the seriousness of the anticipated harm of a novel technology, or (2) a rival regulator attempts to formalize its regulatory authority or fails to do so although officially required to. A historical–institutional analysis of the temporal process leading to jurisdictional claims by the U.S. Food and Drug Administration over gene therapy, laboratory‐developed complex diagnostic tests, human tissue transplants, and human cloning supports the model's prediction.