PASS Coalition Works Toward FDA Acceptance Of New(ish) UV Filters
This article was originally published in The Rose Sheet
The newly formed Public Access to Sunscreens coalition says it plans to work with FDA, legislators and stakeholders to facilitate review of sunscreen actives. The group proposes user fees as one method of ensuring FDA has the resources it needs to complete sunscreen ingredient evaluations, some of which have been pending as time and extent applications since 2002.
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The agency will conduct a public hearing March 25-26 to garner input on improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.
Without swift FDA action on eight sunscreen filters pending review, legislators intend to introduce a bill to alter the agency’s sunscreen approval process. House members questioned FDA Center for Drug Evaluation and Research Director Janet Woodcock on the status of the applications, some of which have been under agency review for more than 10 years.
Consumers would be better equipped against harmful UV radiation if they had access to next-generation sunscreen actives mired in FDA’s Time and Extent Application process, the Public Access to Sunscreens Coalition suggests in comments to the Centers for Disease Control and Prevention. The Personal Care Products Council also submitted comments emphasizing the importance of sunscreen use.