The PASS Coalition recognized 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 is concerned that the 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 today, 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 PASS.
Reasonable deadlines for the FDA to complete its review of ingredients must be adapted when the full committee meets to mark up the legislation to ensure that FDA doesn't continue to drag its feet 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.
American consumers have gone over a decade without the kinds of innovative products our foreign counterparts have enjoyed for years. PASS maintains this is an unnecessarily long timeline that forces consumers to wait that much longer to get the latest products in their hands.
The Sunscreen Innovation Act (H.R. 4250/S. 2141), was recently introduced by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) in the House and Sens. Jack Reed (D-RI) 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, according to PASS. 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. New sunscreen technologies currently awaiting approval in the US 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 US. 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. During the past 40 years, melanoma rates have increased 800% among young women and 400% among young men.