FDA, PCPC To Meet On Sunscreen Work Plan; Industry’s ‘Extended’ Study Timelines A Possible Topic
The US FDA’s deferral of final GRASE rulemaking on UV filters identified in its February proposed rule as lacking data hinges on its acceptance of industry’s work plan. In October, the agency expressed concerns about the plan submitted by the Personal Care Products Council, but granted the group’s request for a meeting – slated for 13 November – to discuss the issues further.
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The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.
Personal Care Product Council submits work plan to FDA setting 2023 date for completing MUsT trial on one of eight UV filters, with additional trials to follow. Research firm considers the estimate consistent with the industry's experience with the trials, but says it could design and conduct the required pilot and pivotal studies in six months.
Industry must provide the agency with a draft plan by 3 Sept. describing the work it intends to conduct to support the generally recognized safety and effectiveness of eight chemical UV filters commonly used on today’s market. Without rulemaking deferrals, the active ingredients’ fate is uncertain as the 26 Nov. statutory deadline for a final OTC sunscreen drug monograph draws near.