FDA DENTAL PRODUCTS PANEL MEETING ON PLAQUE PLANNED FOR MARCH -- GILBERTSON

FDA's dental products panel will "hopefully have its first meeting on plaque in early March," Office of OTC Drug Evaluation Monograph Review Staff Acting Director William Gilbertson said Nov. 13 at the NDMA Research & Scientific Development conference in Washington, D.C. FDA plans to add two new voting members with expertise in dental drugs to the seven-member panel before the March meeting. The two new members will serve on a special five-person subcommittee with responsibility for reviewing plaque issues, Gilbertson explained. Panel industry representative Frederick Curro, PhD, Block Drug VP-clinical research and pharmacology, confirmed that the issues the panel will deal with include whether plaque and tooth whitening claims are drug or cosmetic claims. Review of anti-plaque and gingivitis claims were the reason FDA in 1989 decided to broaden the dental devices panel's scope to include OTC dental products and renamed the group the dental products panel ("The Pink Sheet" Jan. 2, 1989, p. 19). At the time, the agency said it planned to add two new members to the existing panel. Teeth whitening products containing bleaching agents such as hydrogen peroxide came under FDA scrutiny in the autumn of 1991 when eleven warning letters were sent to manufacturers cautioning that such agents have not been proven safe and effective. The additional panel members have not yet been appointed. "Apparently the backlog is in the waiver process and in the conflict of interest [review]. It is backed up and there are priorities with other panels," Curro noted.