Gottlieb to Delayers of Generics: ‘End the Shenanigans’

FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors.

“My message is this: End the shenanigans,” Gottlieb said during a high-level workshop on industry competition, hosted by the Federal Trade Commission.

He pointed to drugmakers’ abuse of REMS programs, which can block manufacturers from obtaining the product samples necessary for developing generics, as well as tactics that otherwise frustrate the process following the end of patent exclusivity.