REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill
Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.
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Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.