PASS comments on the FDA’s Final Guidance regarding O-T-C sunscreen safety and In November, the U.S. Food & Drug Administration (FDA) published Nonprescription Sunscreen Drug Products: Safety & Effectiveness Data–Guidance for Industry, as required by the Sunscreen Innovation Act (Public Law 113–195). The Public Access to SunScreens (PASS) Coalition issued the following statement in response to the FDA’s final guidance: The PASS Coalition’s mission is to work collaboratively with FDA, Congress and stakeholders to ensure Americans have access to the latest sunscreen technology. We are pleased the FDA met the statutory deadline under the bipartisan Sunscreen Innovation Act to publish a final guidance on sunscreen ingredient testing. We support the changes from the earlier draft—especially changes to the formulations and the body surface area to be tested. However, we were disappointed that the agency’s approach remains inconsistent with the recommendations made by independent scientific reviewers that were published in peerreviewed literature. We look forward to continuing to work with FDA and the new Administration to ensure that safe ingredients get to market as quickly as possible. The bipartisan Sunscreen Innovation Act was signed into law by President Obama on Nov. 26, 2014. The law streamlined the approval process for new sunscreen ingredients to ensure that these ingredi- ents receive a transparent review within a predictable timeframe. The intent of the Act was to ensure U.S. consumers gain access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays. 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, according to PASS. 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. Although treatments for melanoma are improving rapidly, the survival rates are still low. Taking steps to prevent melanoma is key, and part of those steps is using the most technologically advanced sunscreen products available. The last over-the-counter (O-T-C) 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 15 years later. According to PASS, 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 20 years. SPrAy May 2017 Spray 39
Spray May 2017
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