REMS And Generics: GPhA Needs Legislation, Continues Education

GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.

The generic industry’s campaign to end some brand companies’ practices of using REMS to prevent competition appears to remain in the education phase with no specific legislative solution upcoming and no obvious regulatory answer.

The group now has some data to bolster its claim that Risk Evaluation and Mitigation Strategy abuse must be stopped....