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Expert Analysis

FDA May Push Boundaries To Speed REMS Negotiations

By Katlin Backfield (July 5, 2017, 3:11 PM EDT) -- The U.S. Food and Drug Administration is reevaluating how it can "lift barriers" to generic competition in an effort to reduce drug prices. As part of this initiative, new FDA Commissioner Dr. Scott Gottlieb has made several strong public statements, including in congressional testimony, that signal an interest in exploring the limits of the agency's authority to curb purported abuses of the risk evaluation and mitigation strategies (REMS) program. The agency is holding a public meeting on July 18 to solicit input on the appropriate balance between innovation and access....

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