Rosen Comments on FDA Commissioner’s Remarks

Partner David Rosen is quoted in a Pink Sheet article, “Gottlieb’s Complex Generics Remarks Could Signal (Some) Increased Flexibility,” about FDA Commissioner Scott Gottlieb’s remarks on generic copies of products with drug and device constituent parts at an internal FDA event for agency scientists and researchers, where he reinforced the agency’s position to permit a generic product to have certain labeling differences from the branded product if the changes are a result of a permitted design difference.

Rosen said Gottlieb’s remarks appear to signal “a little more flexibility” if changes such as those to a delivery device do not raise clinical efficacy or safety issues. That could include a change from “an open-up, actuate, and click-to-actuate” delivery system to a system that has a “lever that you push or pull,” he said.

“I think that it will really be evaluated on a case-by-case basis to make sure that whatever modifications in or changes in the labeling and in these drug-device combination situations don’t raise safety or clinical efficacy types of issues,” he added.