Making modafinil: Classification and serendipity in drug development

Abstract

How does a compound become a drug, and how do we decide for whom the drug is intended? Building a history of modafinil, this article examines how classification and serendipity affect drug development. We explore how mental health categories interact with drug development by tracing: how compound CRL40,476 was inadvertently created while exploring other compounds, and then became a focal point for development efforts; and how it secured Schedule IV status (low potential for abuse), orphan drug status (for niche markets), and then blockbuster drug status (>$1bn in annual sales). Classification of modafinil and its uses were negotiated under conditions of uncertainty, requiring substantial efforts to align interests across a wide array of institutions. We highlight these contingencies to show the considerable efforts that go into finding, and creating, markets for drug development. Taking these efforts for granted may confuse invention with innovation and is likely to lead to understatement of the costs and choices involved in drug development, particularly where mental health categories are concerned.