PASS Coalition to FDA: AmericansNeed Access to the Latest Sunscreen Technology

(Washington, D.C.) — The Public Access to SunScreens (PASS) Coalition expressed major concern over the Food and Drug Administration’s (FDA) position during the recent FDA Nonprescription Drugs Advisory Committee Meeting (NDAC). Even though incidence of skin cancer is rising dramatically and one American every hour dies from melanoma, the discussion at the Meeting signaled that FDA will not be approving new sunscreen products potentially for years to come.

“FDA needs to acknowledge that we have a public health crisis,” said Michael Werner, PASS Coalition Policy Advisor. “New products need to be safe, but the regulatory pathway was created by FDA to specifically allow products on the market if they’ve been used safely elsewhere in the world. According to the Surgeon General’s Call to Action to Prevent Skin Cancer, the government and stakeholders need to be working together to address this immediate and deadly public health crisis.”

Yesterday the FDA approved the sixth melanoma treatment approved since 2011. “While we applaud the FDA’s action in approving this treatment, it continues to restrict Americans’ access to products that will help prevent melanoma that currently are being used all over the world,” Werner continued.

The NDAC meeting comes at a critical time when the Senate is poised to consider the bipartisan Sunscreen Innovation Act, (SIA) that recently moved through and passed out of the House of Representatives by voice vote.

The bipartisan Sunscreen Innovation Act (H.R. 4250/S. 2141), was introduced by Reps. Ed Whitfield (R-Ky.) and John Dingell (D-Mich.) in the House and Sens. Jack Reed (D-R.I.) and Johnny Isakson (R-Ga.) in the Senate. This legislation will streamline FDA’s sunscreen approval process to ensure that new sunscreen ingredients receive a transparent review within a predictable timeframe. This would allow the American public to gain access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays.

The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

Skin cancer is the most common form of cancer diagnosed in the U.S. Each year there are more new cases of skin cancer — including melanoma — than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer. On average, one person dies every hour from melanoma, the deadliest of the skin cancers because of its ability to move quickly and spread to distant organs in the body, and melanoma rates are rising dramatically across demographics. Over the past 40 years, melanoma rates have increased 800 percent among young women and 400 percent among young men.

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