US Senate Committee on Health, Education, Labor, & Pensions

Senators Release Discussion Draft of Bill to Speed FDA Review of Life-Saving Sunscreen Ingredients

Sunscreen Innovation Act, Drafted by Bipartisan group led by Senate HELP Committee Chairman Harkin and Ranking Member Alexander, would establish timeline for FDA review of sunscreens, provide more certainty for makers of over-the-counter drugs

Friday, August 22, 2014

WASHINGTON, D.C.— Senators Tom Harkin (D-IA), Lamar Alexander (R-TN), Jack Reed (D-RI) and Johnny Isakson (R-GA) today released for public comment a draft bill that would require the Food and Drug Administration (FDA) to speed the review process for life-saving sunscreen ingredients and provide more certainty to makers of over-the-counter drugs. 

Currently there are eight applications for new sunscreen ingredients – products that are already available to consumers in other countries –that have been awaiting review by FDA for at least a decade.

“Families in Iowa, and around the country, spend more time outdoors for recreational or work activities and need to be protected from the harmful rays of the sun, especially during the summer.  This legislation would not only allow for new sunscreens to get on the market, faster, but also ensure that there is appropriate FDA review and, ultimately, truth in sunscreen labeling,” said Harkin, Chairman of the Senate HELP Committee. “Today’s bipartisan discussion draft is the first step to passing legislation that will help to provide more certainty to manufacturers on the FDA review process for new sunscreens and ensure that all consumers have access to a wider array of effective sunscreens.”

Harkin continued, “I thank Senators Alexander, Reed, and Isakson for their work on this issue and look forward to joining them and our colleagues in introducing a strong bill that will keep Americans healthier by reducing the risk of skin cancer.”

“Tennesseans and other Americans expect the Food and Drug Administration to act in a timely manner to approve new life-saving drugs and medical devices,” said Alexander, Senate HELP Committee Ranking Member. “Skin cancer is the deadliest cancer in our state and throughout the country, and we know that there are new sunscreens that can help save lives. Our legislation will make sure FDA reviews these new ingredients more quickly and help get new products into the hands of consumers.”

“I appreciate Chairman Harkin and Ranking Member Alexander making this legislation to help consumers and prevent skin cancer a priority.  I wrote this bipartisan bill along with Senator Isakson because we are committed to ensuring U.S. consumers have access to the safest, most effective sunscreens available.  The FDA must do its due diligence to ensure the safety of these products and they should do it in a timely manner.  Americans shouldn’t have to needlessly wait decades for access to the most advanced, effective sunscreens.  By streamlining its review process, the FDA can help consumers better protect themselves from skin cancer and this legislation aims to do just that.  We want Americans to follow safe sun practices and benefit from the latest advances in sun care products and research,” said Reed (D-RI), who originally introduced the bill back in March.

“As a melanoma survivor, I believe it’s essential that Americans have access to safe and effective sunscreen. Too often, technological advancements that have the ability to improve the quality of health care and prevent disease are held back by an overly rigid regulatory process. I am pleased with the bipartisan work my colleagues and I have accomplished in the Sunscreen Innovation Act, and I am confident this legislation will help clear the bureaucratic hurdles that have stood between American consumers and the new and innovative sunscreen products that are already available in many other countries,” said Isakson (R-GA).

The draft legislation builds on S. 2141, introduced by Senators Jack Reed (D-RI) and Johnny Isakson (R-GA) and the House-passed Sunscreen Innovation Act (H.R. 4250), and, while prioritizing sunscreens, improves the regulatory pathway for other over-the-counter drugs that have been stalled at FDA under the current framework.

Skin cancer is the most common form of cancer in the United States, with more than 2 million cases diagnosed every year. A report from the Surgeon General released last month stated that nearly 5 million people in the United States are treated for skin cancers every year, with an annual cost estimated at $8.1 billion. Many of these cases could be prevented by protecting skin from sun exposure, according to the American Cancer Society.

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