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 the bill’s 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 Selig.
“The FDA has approved several new drugs for the treatment of melanoma in 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.
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 US by ensuring that all submissions are reviewed within a predictable timeframe, according to legislators. The Act requires that the current sunscreen backlog be reviewed within eight 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.