FDA will identify companies that have abused REMS agreements to thwart generic and biosimilar competition, FDA Commissioner Scott Gottlieb said Monday. The agency will provide public access to a database that lists complaints from generic and biosimilars companies about branded drug manufacturers improperly using REMS requirements to refuse to provide samples, he said.
The database will be made public Thursday. It will include about 150 complaints FDA has received and will be updated, Gottlieb said.
Separately, Gottlieb said FDA will release guidance that is intended to deal with another kind of REMS abuse, the refusal of branded drug companies to negotiate a shared REMS with a generic or biosimilar competitor. FDA will release guidance in the next two weeks making it easier for generic companies to obtain waivers allowing them to implement their own REMS provisions if negotiations drag on too long, Gottlieb said. He predicted that the guidance will “cut down on this sort of gaming.”