The Citizen Petition: For the Public Good or Brands Behaving Badly?

Abstract

Over the past several years, there has been a perception in the generic industry that brand companies have been using the Citizen Petition process with the US Food and Drug Administration in order to extend the lifecycles of their brand products and prevent or delay approvals of generic applications. While these filings lend credence to this perception, it nonetheless leaves open questions regarding purpose and effect. This paper examines Petition filings since 2004 and explores their purported purpose, their likely purpose, and impact on generic market dynamics.