There was a striking dissonance at the recent US FDA advisory committee review of Takeda Pharmaceuticals USA Inc.’s Uloric (febuxostat) between panelists and agency staff over the role that a Risk Evaluation and Mitigation Strategy (REMS) could or should play in the gout drug’s continued marketing.
On one side were several panelists who believed a REMS should be used for educational purposes to help reinforce with...