Must FDA Treat Similarly-Situated Competitors the Same Way?

December 29, 2010

In his latest article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Director John R. Fleder explores whether the FDA should enforce the FDC Act by giving different treatment to similarly-situated competitors.  The article reaches the conclusion that the public is not well served if companies correctly conclude that they are being held to a harsher standard than their competitors.  Mr. Fleder explains why the best way to avoid this concern is for FDA to take a nationwide approach to enforcement decisions.  He argues that an FDA decision to take an enforcement action must be preceded by an analysis by the agency of whether it is unfairly singling out one competitor for an enforcement action while leaving competitors free from the public stigma of an FDA enforcement action.

Categories: Enforcement