The Public Access to SunScreens (PASS) Coalition is applauding the House Energy and Commerce Subcommittee on Health for passage of the Sunscreen Innovation Act, H.R. 4250. The PASS Coalition applauds the bipartisan support of the Sunscreen Innovation Act and the swift action taken by the subcommittee to help address the urgent public health crisis posed by skin cancer, and particularly melanoma.
Moving forward however, the Coalition still remains concerned that the U.S. Food and Drug Administration (FDA) continues to push to lengthen timelines to review ingredients it has had almost 12 years already to do so, in some cases, which is unacceptable. The coalition has worked hard to accommodate FDA's concerns in the draft vehicle as marked up, but as doctors, public health advocates and ingredient manufacturers have made clear for the past 18 months, Americans have been waiting too long already for these ingredients to be approved.
According to the Coalition, reasonable deadlines for the FDA to complete its review of ingredients need to be adapted when the full committee meets to mark up the legislation to ensure that FDA doesn't continue to delay at the expense of the public's health. These deadlines range from eight months for ingredients that have been pending before FDA, in some cases for 12 years, and 12 months for newly submitted ingredients, as contained in the original bill.
The Sunscreen Innovation Act (H.R. 4250/S. 2141), was recently introduced by Representatives Ed Whitfield (R-Ky.) and John Dingell (D-Mich.) in the House and by Senators 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.
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.
The current membership of the PASS Coalition includes: the Melanoma Research Alliance, the Melanoma Research Foundation, the Prevent Cancer Foundation, The Skin Cancer Foundation, the Sun Safe Tee Program, Dr. Harry Fallick, Dr. Elizabeth Hale, Dr. Henry Lim, Dr. Warwick Morison, Dr. Nadim Shaath, Dr. Steven Wang, Ashland Inc., BASF Corporation, Beiersdorf, DeWolf Chemical, Inc, Fitz Chem Corporation, L’Oréal USA Products, Inc, McCullough & Associates, Procter & Gamble and the Suncare Research Laboratories, A.I.G. Technologies, Product Quest LLC, ROSS Organic, Autumn Harp, Raffaelo, Banana Boat and Hawaiian Tropic-Energizer Holding Company Brands, Akzo Nobel Surface Chemistry LLC, American Cancer Society, American College of Mohs Surgery and the Melanoma International Foundation.