Feb. 10, 2016 SIGN IN | REGISTER

Unlikely Alliance Presses for Sunscreen Approvals

PASS Coalition nets strange bedfellows to push the FDA to approve ingredients that are readily available in other countries

Chris Maddaloni/CQ Roll Call File Photo
Dingell, once a chairman of the House Energy and Commerce Committee, has written to the FDA to question delays approving sunscreen ingredients that have been used overseas for years.

An unusual coalition of skin cancer groups, dermatologists and companies that make sunscreens is prodding Congress and the Food and Drug Administration to speed up approvals for new ingredients to block the sun’s rays.

The Public Access to Sunscreens, or PASS, Coalition, includes such companies as BASF Corp., L’Oreal USA, Ashland Inc., DeWolf Chemical Inc. and Fitz Chem Corp., as well as the Skin Cancer Foundation, the Melanoma Research Foundation and the Prevent Cancer Foundation. Holland & Knight is managing the effort.

“We do not [usually] work with companies who manufacture sunscreen, so this is definitely unique,” said Shelby Moneer, a health educator for the Melanoma Research Foundation. “Our goal is certainly the same as everyone else’s in the coalition.”

The effort is built around getting FDA approval for sunscreen ingredients, or filters, that are already available in other countries but have not yet been cleared for sale in the U.S.

“If there is something better, and the FDA can help get those things approved so they’re available to the consumer, then we’re going to help to prevent those skin cancers,” Moneer said. “We’re not trying to make a bunch of money or do anything that’s downplaying what’s already out there. We’re just hoping to push a little.”

The coalition members say they want to establish a framework for approving the next generation of ultraviolet light active filters for sunscreens sold over the counter. The products have been in use for at least five years in foreign countries.

Al Pearce, senior marketing manager for personal care at the German chemical conglomerate BASF, said some companies like his have been waiting for the FDA for more than a decade.

“Not one ingredient has been approved,” he said, noting that some of the same filters have been in use in Europe since the 1990s.

“We’re approaching various members of Congress in the House and Senate, Republicans and Democrats, to make them aware of the situation,” Pearce said. “We want to work collaboratively with the FDA.”

The companies may be open to a user fee system similar to what’s in place for drug and medical-device evaluations, which Congress would have to authorize.

Already, Rep. John D. Dingell, D-Mich., a former chairman of the House Energy and Commerce Committee, has written to the FDA inquiring about the delay in time and extent applications, or TEAs.

“Skin cancer is becoming a public health epidemic in the United States,” Dingell wrote. “In addition to the public health risks posed by exposure to UV rays, there is a significant fiscal impact associated with the treatment of skin cancer.”

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