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Published: Thursday, 5/22/2014 - Updated: 7 months ago

Looking for protection from under the sun

Skin cancer is target of legislators

BY TOM HENRY
BLADE STAFF WRITER
Brown Brown
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Time to hit the beach, with better sunscreen and more products to choose from.

That’s the message from several members of Congress co-sponsoring legislation called the Sunscreen Innovation Act.

They claim the United States has fallen behind Canada and Europe in the number and quality of sunscreen products, a situation congressmen attribute to U.S. Food and Drug Administration bureaucracy.

With skin cancer on the rise, the bill, introduced in both chambers of Congress in March, requires the FDA to accelerate its review process.

During a conference call with reporters Wednesday, U.S. Sen. Sherrod Brown (D., Ohio) said several Ohio companies manufacture safe sunscreen ingredients that have been used in Canada and Europe for years.

But, he said, many of their applications for new products have been held up by the cumbersome FDA review process for a decade or more.

Seven active ingredients are approved for use in sunscreen sold in Europe, compared with three in the United States, Mr. Brown said.

Currently in committee, the Sunscreen Innovation Act was introduced by U.S. Senators Jack Reed (D., R.I.) and Johnny Isakson (R. Ga.) in the Senate, and U.S. Reps. Ed Whitfield (R., Ky.) and John Dingell (D., Mich.) in the House. Other House co-sponsors include U.S. Rep. Bob Latta (R., Ohio).

It calls for the FDA to maintain the same safety standards, but fast-track consideration of any ingredient once it has been used safely for at least five years in another country.

It ensures that no reviews get started more than 11 months after applications have been filed, and that the FDA submit reports to Congress on its progress within a year after the law is enacted. After that initial report to Congress, the FDA could take up to two years providing updates on the review program.

The FDA, in a statement issued through agency spokesman Andrea Fischer, said it “remains committed to allowing sunscreens containing additional ingredients to be made available to consumers if there is enough data to show that they are generally recognized as safe and effective for use in over-the-counter sunscreens.”

“The FDA recognizes the public health importance of sunscreen use, and has prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency’s resources,” the statement said.

Joining Mr. Brown on the conference call was John Riley, government relations director for Ashland Inc., of Covington, Ky., a manufacturer of sunscreen ingredients. One made at Ashland’s Columbus plant is sold to the makers of European sunscreen, but has not been approved for sale in the United States.

The original application to get approval for the ingredient, called escalol-s, was made in 2005, Mr. Riley said.

“This backlog has gone on for quite some time,” he said. “It’s really mostly a process issue. It has not been a question of the safety or effectiveness of the products. It's one in which the FDA has not made the process work.”

More than 3.5 million cases of skin cancer are diagnosed annually in the United States, according to the American Cancer Society. In 2013, a study by the Archives of Dermatology showed the incidence of nonmelanoma skin cancers in the U.S. increased more than 300 percent since 1994.

Contact Tom Henry at: thenry@theblade.com or 419-724-6079.



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