Citizen petitions: barriers to entry for generic medicines? An update and evaluation of petitions,their management,and disposition from 2004 to 2010

Abstract

In January 2007, the authors published their research findings regarding the filing of citizen petitions with the US Food and Drug Administration. While the research covered petitions filed in the prior two and a half years, the paper addressed the perception that brand companies were abusing the process in an attempt to extend the market lives of their products by filing petitions simply to create additional barriers to entry for generic competition. Later in 2007, Congress passed a law in an attempt to curtail this perceived practice. This paper updates this prior research by examining petition activity over the past seven years, the outcomes, and the law’s impact.