Rosen Comments on FDA Commissioner’s Tenure

Partner David Rosen was quoted in a Modern Healthcare article, “Stakeholders anxious about FDA losing momentum after Gottlieb exits,” about the legacy of Food and Drug Administration Commissioner Dr. Scott Gottlieb, who announced his resignation last week.

Rosen said Gottlieb did a great job improving the generic-drug review and approval process, but that more needs to be done to address branded drugs that have no competition. “I still think the barrier to entry for generics is pretty high,” he said, citing the often insurmountable costs. “Also, the whole issue about patent certification is still subject to a fair amount of debate and clarification.”