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Sunscreen Delays

Lawmakers want FDA to speed up approval process

by Britt E. Erickson
May 12, 2014 | A version of this story appeared in Volume 92, Issue 19

Eight sunscreen active ingredients are currently awaiting FDA approval. The agency recently requested more safety data for amiloxate and diethylhexyl butamido triazone.

It’s spring, and store shelves are packed with sunscreen products. But U.S. consumers have fewer choices than people in many other parts of the world. The reason is because the Food & Drug Administration hasn’t approved any new sunscreen chemicals in more than a decade despite manufacturers’ requests for such approval.

This void of new chemical approvals comes as rates of skin cancer are on the rise, prompting outcries from some lawmakers and patient advocacy groups. They are asking why it is taking FDA so long to approve new sunscreen active ingredients.

For its part, FDA acknowledges that it has a backlog of applications and that the system for reviewing them is broken. The agency wants to overhaul the entire system for approving over-the-counter products that are “generally recognized as safe and effective.” Sunscreens are in that group, but they make up just a small part of it. Lawmakers, however, are anxious to fix the problem with sunscreen approvals and don’t want to wait for FDA to revamp the entire over-the-counter approval process.

At a subcommittee hearing last month in the House of Representatives, members of the Energy & Commerce Committee deliberated over the Sunscreen Innovation Act (H.R. 4250, S. 2141), which would set deadlines for FDA to complete its review of new sunscreen ingredients and clear the current backlog. Companion bills were introduced in March in the House and Senate by Rep. Edward Whitfield (R-Ky.) and Sen. Jack Reed (D-R.I.), respectively.

The Public Access to SunScreens Coalition, a group of sunscreen manufacturers and skin cancer experts, provided input to lawmakers. The coalition was formed last year with the goal of ensuring that sunscreen ingredients are reviewed transparently by FDA in a predictable time frame.

FDA currently has eight applications for new sunscreen ingredients under review, testified Janet Woodcock, head of FDA’s Center for Drug Evaluation & Research. Some of those applications have been with the agency for more than a decade. Earlier this year, FDA responded to two of them, telling manufacturers that the safety data they provided were insufficient.

Real-world conditions of sunscreen use have changed since the 1970s, when FDA first began to regulate sunscreens as over-the-counter drugs, Woodcook explained. At the time, sunscreens were thought to be used on a seasonal basis to prevent sunburn. FDA anticipated that “consumers would be exposed to sunscreen active ingredients in modest amounts and for short, intermittent time periods,” she told lawmakers. “Sunscreen ingredients also were not thought to penetrate beyond the surface of the skin,” she noted.

Today, sunscreens are used generously, year-round by much of the population, including children and babies, resulting in much greater exposure to sunscreen ingredients than in the ’70s. “There is also increasing evidence that some sunscreen ingredients can be absorbed through the skin, leading to systemic exposures to these agents not previously anticipated,” Woodcock said.

The changes in sunscreen use have prompted FDA to raise new questions about what data are needed to show that sunscreens are generally recognized as safe and effective. In particular the agency is concerned about potential endocrine effects and systemic absorption, Woodcock said. FDA plans to hold a public meeting later this year to clarify safety testing requirements for new sunscreen ingredients.

FDA is committed to working with Congress to speed up the approval process, but the final decision on any sunscreen product should rest with FDA, Woodcock stated. The legislation working its way through Congress would give such jurisdiction to an advisory committee.

That provision is a point of concern to some lawmakers—including Rep. Henry A. Waxman (D-Calif.), the top Democrat on the Energy & Commerce Committee. Specifically, FDA would have 45 days to reject any decision made by the advisory committee, but as Waxman pointed out, the onus would be on FDA to show why it is rejecting the decision.


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