A unique alliance of skin cancer groups, dermatologists and sunscreen manufacturers is pushing Congress and the Food and Drug Administration (FDA) to speed up approvals for new sunscreen ingredients. The alliance is called the Public Access to Sunscreens Coalition (PASS Coalition), and includes the Skin Cancer Foundation, the Melanoma Research Foundation, the Prevent Cancer Foundation, as well as companies such as BASF Corp., L’Oreal USA, Ashland Inc., DeWolf Chemical Inc. and Fitz Chem Corp.
Specifically, PASS is lobbying Congress to push FDA to approve sunscreen ingredients, or filters, that have been in use in other countries for at least five years but have not yet been approved for sale in the U.S. They also wish to establish a framework for approving ultraviolet light active filters for sunscreens sold over the counter (OTC). Some companies have indicated they would be open to a user fee system similar to that in place for drugs and medical devices, the Prescription Drug User Fee Act (PDUFA V), and the Medical Device User Fee Amendments (MDUFA III), respectively.
It seems as though this effort is gaining traction, as Representative John Dingell, D-Mich., wrote to the FDA, questioning these differences in approval times. Dingell noted that when FDA established the approval process for these types of products it would “strive to complete [these] evaluations in 90-180 days,” but many of the currently pending applications are for products that have been demonstrated to be safely and effectively used in a foreign country for as long as 15 years.
For drug product to be approved as an OTC, certain information must be submitted in a time and extent application (TEA) to show that the drug product can meet the statutory standard of marketing to a material extent and for a material time. 21 C.F.R. § 330.14.