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.
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