The FDA released new guidance to address efforts by branded drugmakers to use the citizen petition process to stifle competition.
In the draft guidance, the agency describes factors it will weigh while deciding whether a petition is designed to delay a generic application and says it may deny the petition on this basis. Gottlieb said the agency also intends to include a section in its annual report to Congress that highlights petitions deemed to have been submitted to delay generic approvals, which it also plans to refer to the Federal Trade Commission.
“We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients,” Commissioner Scott Gottlieb said. “We’re taking the abuse of this system seriously. And we hope that this increased transparency will reduce gratuitous hurdles to generic drug development and approval.”