On November 26, President Obama sign the Sunscreen Innovation Act (SIA) into law after is was passed in the House of Representatives on November 14. The bill is designed to address a regulatory backlog that is preventing U.S. consumers from having access to advanced, effective sunscreens that are widely available in the rest of the world. The U.S. Senate passed the bill in September.
SIA will help the U.S. catch up to other countries in sunscreen technology by expediting the U.S. Food and Drug Administration’s (FDA) review process for active ingredients in sunscreens that have long been approved for use in places like Europe and Canada. Some of these sunscreen ingredients have been safely used overseas for years, but have had their applications pending before the FDA for more than a decade. SIA also seeks to shed some light on the FDA’s review process by requiring the agency to periodically report to Congress on the progress of this effort.
“The signing of the Sunscreen Innovation Act by President Barack Obama is the culmination of persistent, bipartisan work by Congress and stakeholders to provide Americans with access to the latest sunscreen products to help curb future cases of skin cancer, particularly melanoma,” said Michael Werner, Public Access to SunScreens (PASS) Coalition policy advisor. “We are confident that the new law will enable Americans to have greater choice when it comes to protecting their skin from the sun’s harmful UVA and UVB rays.”
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 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.
With President Obama’s approval of the bipartisan SIA, FDA must now work with applicants, Congress and stakeholders to implement the new law. FDA must render a decision on the eight pending sunscreen application according to statutory timelines created by the legislation, with some decisions expected as quickly as six months from enactment.
“The President’s approval of the Sunscreen Innovation Act demonstrates that the White House and Congress agree that FDA should ensure all sunscreens receive a transparent review within a predictable timeframe,” Werner said. “With this law, Congress has helped answer the U.S. Surgeon General’s Call to Action to Prevent Skin Cancer. The PASS Coalition and other stakeholders will now focus on working with FDA to guarantee the new law is implemented as quickly as possible.”