Manufacturers Argue FDA Sunscreen Reviews Keep Outside Science In Shade
This article was originally published in The Pink Sheet
FDA officials and the Public Access to Sunscreen Coalition will meet Nov. 1 in effort to find common ground between FDA and outside scientists on standards for testing requirements of new sunscreens under one of four draft guidances the agency is scheduled to finalize by the end of the year.
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Changes in tentative final OTC sunscreen monograph would increase testing costs than FDA estimates and leave consumers with fewer, more expensive products to choose from, say CHPA and PCPC. Firms estimate testing costs will increase roughly 25% to 30% based on proposed changes in protocols.
Spaulding Clinical, which the FDA contracted for its sunscreen maximal usage trial published in May, is in discussions with a handful of sunscreen industry players about doing more MUsTs to fulfill data needs identified by the agency. Meanwhile, leading trade groups are interested in talking to the FDA about developing sunscreen study protocols that more accurately reflect real-world consumer usage.
FDA final guidance on MUsTs for topically applied ingredients for OTC drug monograph affirms draft, not incorporating changes pushed by industry. CHPA says FDA’s MUsT study published recently finding sunscreen actives penetrate skin to bloodstream at higher levels than previously believed demonstrates "value" of test method.