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Gottlieb Talks Activist Role For FDA In Curbing REMS Abuse

 
• By Michael Cipriano

US FDA commissioner says he would be happy to work with Congress on a legislative solution on the issue, but emphasized his priority is for the agency to develop a system itself to discourage REMS abuse.

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Although the issue of misuse of risk evaluation and mitigation strategies (REMS) and non-REMS restricted distribution systems to prevent generic competition from reaching the market has been touted in recent months as one needing a legislative solution, US FDA Commissioner Scott Gottlieb is eyeing on a more active role for the agency to play on the subject.

Gottlieb told the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies on June 20...

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