Senators Jack Reed (D-RI) and Johnny Isakson (R-GA), and Congressmen Ed Whitfield (R-KY) and John Dingell (D-MI) have introduced the bipartisan, bicameral Sunscreen Innovation Act (H.R. 4250), which would amend the Food Drug & Cosmetic Act to ensure all sunscreen ingredients receive a transparent review within a predictable timeframe.
The Public Access to SunScreen (PASS) Coalition applauds introduction, noted Wendy Selig, president and CEO of the Melanoma Research Alliance, an active member of the coalition.
"This legislation is a responsible way to alleviate the current 12 year backlog of sunscreen ingredients, and streamline the review process so the public can gain access to the most effective and innovative sunscreen products,” said Wendy Selig, president and CEO of the Melanoma Research Alliance
"The FDA has approved several new drugs for the treatment of melanoma in the recent years, and these drugs have made a profound impact on the lives of many patients with advanced disease. Now, it is time for the FDA to focus on prevention of skin cancers and approve the sunscreen ingredients that can better protect the public from harmful ultraviolet rays,” noted Dr. Steven Wang, board-certified dermatologist at Memorial Sloan Kettering Cancer Center and member of the PASS Coalition.
Here are some details on the legislation:
Under the proposal, existing FDA eligibility requirements will be maintained; an ingredient must be used safely for at least five years in at least one country. Eligibility determinations will be made by the FDA Division of Nonprescription Regulation Development (DNRD). Pending ingredient submissions -- already deemed eligible by FDA -- will be considered eligible for the new review and approval process. After a finding of eligibility, the ingredient application will be submitted to the existing FDA Nonprescription Drugs Advisory Committee (NDAC), for a safety and effectiveness recommendation. During the review process, the Advisory Committee will receive data from the public and communicate with the application’s sponsor to seek clarifying or request additional information. The FDA will concur or deny the Committee's recommendation.
The Sunscreen Innovation Act will spur further innovation in sunscreens in the U.S. by ensuring that all submissions are reviewed within a predictable timeframe. The Act requires that the current sunscreen backlog be reviewed within 8 months and new submissions be reviewed within 11 months.
FDA is required to submit reports to Congress regarding the progress of the program 12 months following enactment and every two years thereafter.
According to Al Pearce, senior marketing manager/personal care at BASF Corporation, the PASS Coalition strongly encourages swift legislative action in both the House and the Senate to see the Sunscreen Innovation Act become law."
The current membership of the PASS Coalition includes the Melanoma Research Alliance, the Melanoma Research Foundation, the Prevent Cancer Foundation, The Skin Cancer Foundation, the Sun Safe Tee Program, Dr. Harry Fallick, Dr. Elizabeth Hale, Dr. Henry Lim, Dr. Warwick Morison, Dr. Nadim Shaath, Dr. Steven Wang, Ashland Inc., BASF Corporation, Beiersdorf, DeWolf Chemical, Inc, Fitz Chem Corporation, L’Oréal USA Products, Inc, McCullough & Associates, Procter & Gamble and the Suncare Research Laboratories, A.I.G. Technologies, Product Quest LLC, ROSS Organic, Autumn Harp, Raffaelo, Banana Boat and Hawaiian Tropic-Energizer Holding Company Brands.