GOVERNMENT & POLICY
first began to regulate sunscreens as overthe-counter drugs, Woodcook explained. At the time, sunscreens were thought to be used on a seasonal basis to prevent Lawmakers want FDA to speed up APPROVAL PROCESS sunburn. FDA anticipated that “consumers would be exposed to sunscreen active ingredients in modest amounts and for IT’S SPRING, and store shelves are packed lawmakers. The coalition was formed last short, intermittent time periods,” she told with sunscreen products. But U.S. conyear with the goal of ensuring that sunlawmakers. “Sunscreen ingredients also sumers have fewer choices than people in screen ingredients are reviewed transparwere not thought to penetrate beyond the many other parts of the world. The reason ently by FDA in a predictable time frame. surface of the skin,” she noted. is because the Food & Drug Administration FDA currently has eight applications for Today, sunscreens are used generously, hasn’t approved any new sunscreen cheminew sunscreen ingredients under review, year-round by much of the population, cals in more than a decade despite manutestified Janet Woodcock, head of FDA’s including children and babies, resulting facturers’ requests for such approval. Center for Drug Evaluation & Research. in much greater exposure to sunscreen This void of new chemical approvals Some of those applications have been with ingredients than in the ’70s. “There is also comes as rates of skin cancer are on the the agency for more than a decade. Earlier increasing evidence that some sunscreen rise, prompting outcries from some lawthis year, FDA responded to two of them, ingredients can be absorbed through the makers and patient advocacy groups. They telling manufacturers that the safety data skin, leading to systemic are asking why it is taking FDA so long to they provided were insufficient. exposures to these agents approve new sunscreen active ingredients. Real-world conditions of sunscreen use not previously anticipated,” For its part, FDA acknowledges have changed since the 1970s, when FDA Woodcock said. that it has a backlog of applicaThe changes in sunscreen O tions and that the system for use have prompted FDA to raise O reviewing them is broken. The O O new questions about what data O O HN agency wants to overhaul the are needed to entire system for approving show that sunO O N N over-the-counter products screens are genN N N O H H that are “generally recogerally recognized as Enzacamene Octyl triazone nized as safe and effective.” safe and effective. In particular the OCH3 Sunscreens are in that group, agency is concerned about potential UNDER REVIEW but they make up just a small endocrine effects and systemic absorpAmiloxate Eight sunscreen active part of it. Lawmakers, howtion, Woodcock said. FDA plans to ingredients are currently OCH3 ever, are anxious to fix the hold a public meeting later this year to awaiting FDA approval. The problem with sunscreen apclarify safety testing requirements for agency recently requested provals and don’t new sunscreen ingredients. more safety data for want to wait for FDA is committed to workN amiloxate and diethylhexyl HO N N OH FDA to revamp ing with Congress to speed up N butamido triazone. N N the entire overthe approval process, but HO the-counter apthe final decision on O O proval process. any sunscreen product HO N N N At a subcommittee hearing should rest with FDA, last month in the House Woodcock stated. The Bisoctrizole of Representatives, legislation working its Bemotrizinol members of the Energy way through Congress O & Commerce Commitwould give such jurisO O tee deliberated over the diction to an advisory O S OH O O HN Sunscreen Innovation committee. Act (H.R. 4250, S. 2141), That provision is a N O N N H which would set deadpoint of concern to some N N N O lines for FDA to complete lawmakers—including H H HO S O its review of new sunscreen Rep. Henry A. Waxman Diethylhexyl butamido triazone O ingredients and clear the cur(D-Calif.), the top Terephthalylidene dicamphor sulfonic acid rent backlog. Companion bills were Democrat on the N introduced in March in the House and Energy & Commerce Committee. SpecifiN N Senate by Rep. Edward Whitfield (R-Ky.) cally, FDA would have 45 days to reject any CH3 HO and Sen. Jack Reed (D-R.I.), respectively. decision made by the advisory committee, Si OSi(CH3)3 The Public Access to SunScreens Coalibut as Waxman pointed out, the onus would OSi(CH3)3 tion, a group of sunscreen manufacturers be on FDA to show why it is rejecting the Drometrizole trisiloxane and skin cancer experts, provided input to decision.—BRITT ERICKSON
SUNSCREEN DELAYS
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MAY 12, 2014
