FDA’s ‘Exploratory’ MUsT Won't Affect OTC Sunscreen Rulemaking Schedule
This article was originally published in The Rose Sheet
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.
You may also be interested in...
In FDA’s maximal usage trial published May 6 in JAMA, oxybenzone, octocrylene, avobenzone and ecamsule all absorbed into subjects’ bloodstreams at levels that raise systemic safety questions. The active ingredients are among 12 that FDA identified in a February proposed rule as currently lacking data to support continued GRASE status.
Following FDA’s proposed sunscreen rule in February, the Consumer Healthcare Products Association has opened a line of communication with the American Cleaning Institute to gain insight into the GRASE data delivery process that kicked off for consumer antiseptic products in September 2016.
Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance
Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.