An Antidote to Efforts by Drug Manufacturers to Delay the Entry of Generic Competition via Sham Petitioning

BY Ana Jemec Friedman

With generic pharmaceuticals costing only a fraction of their brand-name counterparts, access to generic pharmaceuticals can significantly benefit American consumers. However, this access to generic pharmaceuticals also yields a detriment to brand-name manufacturers’ profitability. As a result,  some brand-name manufacturers have attempted to extend their pharmaceuticals’ exclusivity through various tactics, including filing sham citizen petitions with the FDA in an effort to delay the FDA’s approval of generic equivalents.

Because the ability to file citizen petitions originates in the First Amendment, parties filing such petitions enjoy broad protection from antitrust liability under the Noerr-Pennington doctrine. Further, the FDA itself has recognized that Congress’s attempt to curb abuse of the petition process through the FDAAA has not been entirely successful. This Comment proposes an alternative regulatory approach that addresses outstanding concerns of anticompetitive abuse of the citizen petition process. The approach balances the two competing goals of discouraging parties from abusing the petition process while also encouraging parties to submit petitions raising concerns regarding the potential safety of generic pharmaceuticals awaiting FDA approval.

DOWNLOAD PDF | 92 N.C. L. Rev. 277 (2014)