PASS Reacts To Sunscreen TEA Denials: Has FDA ‘Moved The Goal Post’?
This article was originally published in The Rose Sheet
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.
You may also be interested in...
FDA’s plans for a maximal usage study to better understand sunscreen ingredient absorption should not hold up delivery of a final OTC sunscreen monograph by the end of 2019, the agency says. There are questions among industry stakeholders as to how FDA’s research relates to MUsTs currently requested from TEA sponsors seeking GRASE approvals.
Inspections conducted over the past year may have contributed to a wider FDA crackdown on unapproved sunscreen drug products – specifically those in dosage forms deemed ineligible under OTC drug review for inclusion in the sunscreen monograph – with five marketers targeted so far this month with warning letters.
"The Rose Sheet" examines the Environmental Working Group's assertion that half of the US sunscreens it evaluated for its 2016 report and shopping guide likely would not be marketable in Europe due to inadequate UVA protection. The NGO's suggestion that sunscreen's capacity for preventing skin cancer has not been demonstrated also invites scrutiny.