OTC Monograph Reform Passage Press Release

Congress Passes Important Legislation to Help Speed New Sunscreens to Market in Coronavirus Package

For Immediate Release: March 27, 2020
Contact: Ethan Jorgensen-Earp, ethan.jorgensen-earp@hklaw.com

The Public Access to SunScreens (PASS) Coalition, an alliance of public health organizations, physician groups, sunscreen manufacturers and concerned citizens, applauds Congress for including and passing the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (S. 2740) in its most recent legislative package to address the coronavirus, the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748). This legislation represents an important step forward in creating a process to speed new sunscreens to Americans to protect them from the hazards of skin cancer. It also addresses the regulatory status of currently marketed sunscreen ingredients to ensure continued access to these products.
According to the Surgeon General nearly 5 million Americans each year are treated for skin cancer, making it the most common form of cancer in the United States. Treatments for skin cancer result in $8.1 billion per year in health care spending. The alarming rate of skin cancer means that each year there are now more new cases of skin cancer than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer. Melanoma, attributed primarily to UV exposure, is the most deadly form of skin cancer causing one death per hour in the United States.

Sunscreen, in addition to UV protective clothing, sunglasses and limiting exposure to direct sunlight, continues to be an essential tool for preventing skin cancer. However, it has been over 20 years since the FDA approved a new sunscreen ingredient through the monograph process. This is despite the fact that many of these ingredients have been available in other countries across the world and offer superior protection from the sun.

This legislation would make important changes to how FDA considers new OTC products, including sunscreen ingredients that have been held up under FDA’s outdated monograph process. In addition, the legislation would offer a period of marketing exclusivity to new sunscreen ingredients approved under the new process and would allow companies to meet collaboratively with the FDA as their ingredient applications are considered. The legislation would also provide new resources to the FDA to evaluate new OTC products through user fees, which have been used to bolster the FDA’s funding in its consideration of other medical products, like prescription drugs and medical devices.

“Access to the latest sunscreen technology is extremely important for protecting Americans from skin cancer,” says Michael Werner, Policy Advisor to the PASS Coalition. “This legislation represents an important step forward for speeding new and effective sunscreens to market. The PASS Coalition advocates for the safest, most effective and innovative sunscreens that will help us reverse the trends that make skin cancers the most common form of cancer in the United States.”

The PASS Coalition is an alliance of public health organizations, physician groups, sunscreen manufacturers, and concerned citizens whose mission is to help prevent skin cancer and improve public health by ensuring Americans have access to safe and effective sunscreens and evidence-based education on sun-safe practices.

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