Healthcare Supply Chain
March 15, 2013
The Public Access to SunScreens Coalition suggests a user fee program to help expedite FDA review of time and extent applications for OTC sunscreen ingredients proposed for introduction in the U.S.
During a March 14 press briefing in Washington to kick-off its campaign, PASS said it plans to meet with FDA and will recommend the user fee program.
“Despite a number of OTC applications waiting for approval for several years, FDA has not completed the review of applications for any new sunscreen components,” the coalition, comprising manufacturers, dermatologists and research and health care advocacy groups, says in a same-day release.
Al Pearce, BASF Corp.’s senior marketing manager, personal care North America, pointed out the TEA pipeline is full of sunscreen ingredients available in other markets with “proven benefits to consumers.”
“We need to establish a clear pathway for these products to be reviewed quickly and thoroughly,” Pearce said during the briefing.
He added that user fees already work well to help fund FDA’s evaluations of new drug applications and animal drug TEA reviews.
FDA also receives user fees to support its work in food safety and in generic Rx drug reviews. However, Congress, not the agency, has authority to create user fee programs. In its fiscal 2013 budget request, the Obama administration suggested establishing user fees for domestic and foreign manufacturers of cosmetics, including mouthwashes, but lawmakers have not agreed.
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