Brand Companies Attempt To Parlay FDA’s Focus On Generics Into More Exclusivity

December 13, 2017 at 4:48 PM
Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition. Consumer advocacy group Public Citizen called the move “grossly out of touch,” but a generic industry source was less willing to place blame. Many of the same groups also argue distribution restrictions on drugs via Risk Evaluation and Mitigation Strategies (REMS), which FDA Commissioner Scott Gottlieb has...


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