PASS Reacts To Sunscreen TEA Denials: Has FDA ‘Moved The Goal Post’?
This article was originally published in The Rose Sheet
Executive Summary
The Sunscreen Innovation Act may have served to clear FDA’s queue of pending sunscreen TEAs, but with denials across the board due to insufficient data, the Public Access to Sunscreens coalition questions the tenability of FDA’s standards and approach to review. The denial of L’Oreal’s TEA for ecamsule, an ingredient already available OTC through a new drug approval, only reinforces PASS’ view that FDA is resistant to working outside of the NDA pathway.