Brand Exclusivity 'Gaming' To Be Addressed At US FDA Meeting

May 26 2017

• By Michael Cipriano

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Commissioner Gottlieb outlines several steps agency is taking – including potentially dropping requirement for shared REMS – to create more competitive generic marketplace.

Man crushed by Pill

Newly sworn in FDA Commissioner Scott Gottlieb is beginning to put his stamp on the agency in an effort to foster more robust competition in the generic marketplace, as the agency will hold a public meeting to solicit ideas on how to stop companies from "gaming" the regulatory system and having longer exclusivity periods than Congress intended for their products.

Gottlieb said at a May 25 House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies...

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