Public Access to SunScreens Coalition Concerned that FDA Has No Clear Timeline for Sunscreen Ingredient Approvals at FDA Budget Hearing

FDA Commissioner Hamburg Indicates Issue is a Priority, Yet Some Sunscreen Applications Have Been Pending for Ten Years

(Washington, DC) — On Friday, April 26th, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies held a hearing with FDA Commissioner Margaret Hamburg regarding the Fiscal Year 2014 budget request for FDA.

During this hearing, Subcommittee Ranking Member Sam Farr (D-CA) shared a compelling, personal story about his brother-in-law, who was an avid outdoorsman diagnosed with melanoma that ultimately proved fatal (hearing video available at C-Span beginning at 28m35s).  Ranking Member Farr expressed his concern that FDA had not acted upon any of the eight pending sunscreen ingredient applications that have been pending for over a decade and asked Commissioner Hamburg to explain the delay in taking action on these applications.

While the Public Access to SunScreens (PASS) Coalition was encouraged to hear that the FDA considers sunscreen safety a priority, the Coalition was concerned that Commissioner Hamburg had no details as to when the decade-long delay would be addressed, and new sunscreen ingredients would be approved.

The PASS Coalition thanks Congressman Farr for sharing his personal story and expresses its condolences for his family loss to melanoma.  We appreciate Ranking Member Farr pressing the FDA to address the growing skin cancer epidemic in the United States by ensuring Americans have access to the latest effective sunscreens.  According to the Skin Cancer Foundation, over 75,000 new cases of invasive melanoma will be diagnosed in the U.S. this year and nearly 10,000 people will not survive melanoma in 2013.  The American people need access to safe and effective broad-spectrum, photostable UV screens to protect themselves against the harmful effects of the sun.  The PASS Coalition looks forward to continuing to work with the FDA to seek a timely regulatory pathway to market for new and effective sunscreen ingredients in the United States.

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 Over-the-Counter (OTC) sunscreens.

The current membership of the PASS Coalition includes: The Skin Cancer Foundation, Prevent Cancer Foundation, Melanoma Research Foundation, Dr. Harry Fallick, Dr. Henry Lim, Dr. Nadim Shaath, Dr. Steven Wang, Beiersdorf, L’Oréal USA Products, Ashland Inc., BASF Corporation, DeWolf Chemical, Fitz Chem Corporation, McCullough & Associates.

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