FDA Citizen Petitions : A New Means of Delaying Generic Entry?

Food and Drug Administration (FDA) citizen petitions have received attention as a possible means of inhibiting generic pharmaceutical competition. Citizen petitions are submissions designed to alert the FDA to possible scientific and safety issues related to regulated products or agency procedures. Generic pharmaceutical companies have alleged that branded pharmaceutical companies have improperly used citizen petitions to block or delay entry of generic competitors by raising frivolous or untimely concerns about generic companies’ Abbreviated New Drug Applications (ANDA). Yet to date, there is little evidence that citizen petitions by branded pharmaceutical companies have injured competition by delaying generic entry. As a result, Federal Trade Commission (FTC) appears to have little interest in investigating or challenging these filings. Private actions to challenge this practice are likely to face significant challenges overcoming Noerr immunity and establishing antitrust injury