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REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill

 
• By Michael Cipriano

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.

Capitol House

A bipartisan group of lawmakers is hoping that reintroduced legislation will stop innovator drug companies from blocking access for generic sponsors to products subject to Risk Evaluation and Mitigation Strategies (REMS) "without a legitimate business justification."

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S.974) – sponsored by Sen. Pat Leahy, D-Vt., and cosponsored by Senate Judiciary Committee Chairman Chuck Grassley, R-Iowa, Ranking Member Sen. Dianne Feinstein, D-Calif. and committee members Sens. Amy Klobuchar, D-Minn

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