PASS Coalition Commends Dr. Robert Califf for His Commitment to Work to Ensure New Sunscreens Get to Market

 On the Brink of Year Anniversary of the Sunscreen Innovation Act Becoming Law,
Nothing Has Changed Except Rising Melanoma Rates


(Washington, D.C.) —The Public Access to SunScreens (PASS) Coalition today commended Dr. Robert Califf on his public commitment to work with Senator Johnny Isakson (R-GA), other congressional leaders, and stakeholders to ensure new sunscreens are available in the U.S. in a reasonable timeframe as laid out by the Sunscreen Innovation Act signed into law in 2014. Dr. Califf expressed these comments today during his confirmation hearing for Commissioner of the Food and Drug Administration, (FDA).

“We are pleased that, in response to a question from Senator Isakson during his confirmation hearing, Dr. Califf expressed his commitment to working together with patient groups, cancer groups, and other stakeholders to bring new sunscreen ingredients to the U.S. market,” said Michael Werner, PASS Coalition Policy Advisor. “Senator Isakson, a melanoma survivor himself, rightly pointed out that on November 26th, it will be a year since the Sunscreen Innovation Act became law and still the FDA not reached an agreement with stakeholders on an appropriate approval standard for new sunscreen ingredients in spite of increased U.S. melanoma rates. Dr. Califf, who also has a family history of melanoma, acknowledged that we have to do better at preventing melanoma.”

“Americans have gone more than a decade without the kinds of innovative sunscreen products citizens in other countries have enjoyed for years. Meanwhile, skin cancer has become a public health crisis that is only getting worse according to the U.S. Surgeon General and Centers for Disease Control,” said Werner.

“When the bipartisan Sunscreen Innovation Act was signed into law last year, Americans expected that they would soon be able to get the latest in sunscreen technology long available to citizens of countries all over the world. But almost one year has gone by and the FDA still has not approved these sunscreens despite their track record of safety and effectiveness,” Werner concluded. “We are hopeful that when confirmed, Dr. Califf will work with Senator Isakson and stakeholders to get these new ingredients to market in the near future.”

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.  From 1975-2011, rates of melanoma in young men and women ages 20-39 years increased by 34% in men and by 84% in women.  According to the Surgeon General, nearly 5 million Americans are diagnosed with skin cancer and one person dies every hour of every day from melanoma, the deadliest skin cancer.  The cost to treat skin cancer is over $8 billion, which doesn’t include the pain and suffering for families that lose their loved ones from the disease.  The Surgeon General and  CDC both regularly call on Americans to wear sunscreen to prevent skin cancer.

The bipartisan Sunscreen Innovation Act (Public Law No: 113-195) streamlined the approval process for new sunscreen ingredients to ensure that new sunscreen ingredients receive a transparent review within a predictable timeframe. The law was intended to ensure the American public gains 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 final decisions 13 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.

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The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies, and concerned citizens who will work collaboratively with the FDA, the White House and Congress to establish a timely and transparent framework for approval of the next generation of UV active filters for OTC sunscreens. Click here to see the full membership of the PASS Coalition.

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