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REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

 
• By Michael Cipriano

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

Generic drug manufacturers appear to have had the most trouble obtaining access to samples from Celgene Corp. and Johnson & Johnson unit Actelion Pharmaceuticals Ltd., as the US FDA has released its list of inquiries and safety determination letters sent to brand companies in the agency's battle against misuse and abuse of risk evaluation and mitigation strategies (REMS) and other innovator gaming methods.

In total, generic companies have sent 164 inquiries to FDA about 52 innovator drugs, with the agency sending out 21 safety determination letters, according to reference listed drug (RLD) access inquiries

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