REMS Reform Seems Distant Goal For Generics After Limited Support At US House Hearing
Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.
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Brand drug representative tells Senate subcommittee there are problems with bill that would make it easier for generics to obtain samples, but did not appear interested in scrapping it.
Senate bill would allow generic companies to bring civil suits against brand sponsors that use REMS requirements to avoid providing samples for testing.
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.