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PASS Supports FDA's OTC Monograph Review

February 25, 2014

Urges Administration to act on pending sunscreen applications.

The Public Access to SunScreens (PASS) Coalition supports the Food and Drug Administration's newly scheduled March public meeting to obtain input on the Over-The-Counter, (OTC) Monograph Drug Review. However the coalition was quick to point out that while these efforts are necessary for revising the OTC monograph system in general, the FDA needs to do more to address the urgent public health need so that the American consumer has access to the latest, innovative sunscreen ingredients.
 
PASS notes that at a time when cases of skin cancer have reached epidemic levels in the US, outnumbering the occurrence of all other cancers, and one American dies every hour from melanoma, it is imperative for Americans to have access to the latest safe and effective sunscreen products available. Yet this is the second time in five years that the FDA has held public meetings regarding the OTC monograph process relevant to sunscreen approvals, without approving any of eight pending sunscreen applications, some of which have been backlogged for over 10 years.
 
The persistent delays in sunscreen approvals have caught the attention of Congress and bipartisan legislation will be introduced to reform the sunscreen application process in the very near future. This legislation will ensure that Americans have access to the latest safe and effective sunscreen ingredients in a timely fashion.
 
PASS strongly urges the FDA to work with Congress to clear the 10-year backlog in sunscreen applications and reform the review and approval process to help provide Americans with the tools they need to combat the sun's harmful UV rays and rising skin cancer rates. Sunscreen technology currently awaiting approval before the FDA has been widely available in Europe, Asia, Central and South America, in some cases for over 15 years.

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