Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the introduction of generic and biosimilar competition. This is evident from a recent report from the FDA to Congress and the settlement of a private antitrust suit.

In its November 2014 Sixth Annual Report to Congress following up on 2007 legislation, the FDA warned that congressional efforts to curtail the use of citizen petitions as a delay tactic may be ineffective, stating that the legislation may not be “discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and that do not raise valid scientific issues.” Meanwhile, a $98 million settlement reached last month in a multidistrict antitrust litigation alleging illegal monopolization through a brand’s filing of an “objectively baseless” citizen petition suggests that courts remain willing to entertain the misuse of a citizen petition as the grounds for an antitrust violation.