A Senate committee today unanimously passed legislation by U.S. Senators Johnny Isakson, R-Ga., and Jack Reed, D-R.I., that seeks to address a regulatory backlog that is blocking U.S. consumers from access to innovative sunscreens widely available in the rest of the world.
The Sunscreen Innovation Act was approved by the Senate Committee on Health, Education, Labor and Pensions today in a unanimous voice vote, advancing the measure to the full Senate for consideration.
“As a melanoma survivor, I believe it’s essential that Americans have access to the most safe and effective sunscreen,” said Isakson. “Too often, technological advancements that have the ability to improve the quality of health care and prevent disease are held back by an overly rigid regulatory process. I am hopeful this legislation will help clear the bureaucratic hurdles that have stood between American consumers and the new and innovative sunscreen products that are already available in many other countries.”
“This bipartisan, commonsense legislation will help consumers better protect themselves from skin cancer by safely accelerating access to the latest advances in sun care products and research, and I am glad it’s on the way to becoming law” said Reed. “The FDA must do its due diligence to ensure the safety of these products and they should do it in a timely manner. It’s important for people to protect themselves from the sun, and Americans trying to shield themselves and their families from harmful rays shouldn’t have to wait decades for access to the most advanced, effective sunscreens available.”
As skin cancer rates continue to climb, the Isakson-Reed legislation seeks to expedite 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 such as Europe, Canada, and other countries.
Some of these sunscreen ingredients have been safely used overseas for years, but have had their applications pending before the FDA for a decade or more. The Sunscreen Innovation Act 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.
Skin cancer is the most common form of cancer in the United States, with more than 2 million cases diagnosed every year. A recent report from the Surgeon General stated that nearly 5 million people in the U.S. are treated for skin cancer every year, with an annual cost estimated at $8.1 billion. Many of these cases could be prevented by protecting skin from sun exposure, according to the American Cancer Society.
The Sunscreen Innovation Act will amend the Federal Food Drug and Cosmetic Act to ensure all sunscreen ingredients receive a transparent review within a predictable timeframe. Key aspects of the bill include:
• Maintains existing FDA safety and efficacy requirements for sunscreens, while streamlining the FDA review process for new ingredients found eligible for this review because of safe use for at least five years in at least one other country.
• Provide an option for ingredients that are currently awaiting FDA action to be considered by an external Advisory Committee as part of the FDA review process.
• Help reduce the current backlog of sunscreen applications and ensure a more predictable regulatory pathway for new sunscreen applications.
• Require regular reporting by FDA on efforts to reduce the backlog of applications and to review new sunscreen ingredients, as well as independent reporting by the Government Accountability Office on the sunscreen approval pathway and the broader over-the-counter (OTC) regulatory scheme.
• Require the FDA to finalize the regulations governing all OTC sunscreens within five years, including any new sunscreen ingredients reviewed by the FDA as a result of this legislation.
The full Senate could consider the bill later this week. The U.S. House of Representatives already approved it.
