Enacting New Sunscreen Legislation

With new sunscreen ingredients pending before the FDA for over a decade, our Public Policy & Regulation Group rallied health groups, dermatologists, manufacturers and key government leaders on behalf of the PASS Coalition to advocate for a resolution. Holland & Knight successfully built bipartisan ties to get the Sunscreen Innovation Act passed, which in turn will provide access to effective sunscreens.
Enacting New Sunscreen Legislation

In the United States, skin cancer is the most common form of cancer. Each year there are more new cases of skin cancer than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer. As a result, in 2014 the U.S. Surgeon General issued A Call to Action to Prevent Skin Cancer stating: "Even though most skin cancers can be prevented, rates of skin cancer, including melanoma, are increasing in the United States." According to the Surgeon General, skin cancer impacts 5 million Americans annually at a cost of $8.1 billion.

Costly treatments and excruciating, debilitating pain is the reality for individuals who suffer from skin cancer, specifically melanoma, the deadliest form of skin cancer. Yet this scenario can largely be prevented through the proper use of the latest and most effective sunscreens.

Despite the growing public health risk of skin cancer, FDA has delayed review of new sunscreen ingredients. Since 2002, eight new sunscreen applications have been filed and still await full review. 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. This led skin cancer and public health groups, dermatologists, sunscreen manufacturers and others to seek out Holland & Knight's Public Policy & Regulation Group to develop a strategy to clear the sunscreen application backlog.

For the past few years, the firm's attorneys and policy advisors have been instrumental in the formation, development, and management of the PASS Coalition. The Coalition's goal is to work collaboratively with the FDA, the White House, Congress, health providers, consumer organizations and sunscreen manufacturers to establish a transparent process for pre-market approval of sunscreen components. Today, its membership has grown to include organizations such as the American Cancer Society Cancer Action Network, The Skin Cancer Foundation, the Melanoma Research Alliance, the Melanoma Research Foundation, BASF, Ashland, L'Oréal, and others.

During the 113th Congress, the PASS Coalition sought to advance the Sunscreen Innovation Act. The bipartisan Sunscreen Innovation Act streamlines the approval process for new sunscreen ingredients by creating a new regulatory pathway and establishing a timeframe for FDA review with fixed deadlines. Due to the PASS Coalition's efforts, the Sunscreen Innovation Act was signed into law by President Barack Obama, after unanimously passing both the House and Senate.

"In the U.S., one person dies every hour from melanoma and the number of skin cancer cases has risen dramatically," noted Wendy Selig, president and CEO of the Melanoma Research Alliance, an active member of the PASS Coalition. "… This legislation is a responsible way to alleviate the current 12-year backlog of sunscreen ingredients."

The bill overcame the fiercely divided and partisan 113th Congress, which enacted fewer new laws than any other Congress since World War II. Holland & Knight advocated for the passage of the Sunscreen Innovation Act through a comprehensive campaign that combined lobbying and grassroots efforts with press and social media outreach, including a public service announcement (PSA) broadcast on YouTube.

Holland & Knight's work with the PASS Coalition that led to enactment of the Sunscreen Innovation Act has been recognized by Washington newspaper The Hill as one of the "Top 10 Lobbying Victories of the Year," a tribute to the firm's expertise in lobbying and advocacy. Holland & Knight is a strong conduit for change and, as clients face similar challenges, they can turn to Holland & Knight for leadership and assistance in navigating the field of government relations. Specifically, Holland & Knight's Public Policy & Regulation Group has become a proven leader in developing broad based coalitions to tackle the most complex regulatory and legislative challenges.

Holland & Knight's model for success building broad-based coalitions can be replicated. Toward that end, the firm's Public Policy & Regulation Group will partner with clients to ensure their legislative goals are highly visible before federal policymakers through lobbying and advocacy efforts, combined with press outreach, including traditional and social media. The firm's access to nationwide resources across a range of practices, political prowess, policy depth and media savvy become an extension of a client's team during a coalition project. As illustrated by the success of the PASS Coalition, this leads to desired results for clients.

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