FDA Dental Plaque Advisory Panel Issues Draft Report

Date: Nov 03, 1998

Since late 1990, the Food and Drug Administration (FDA) has been working to develop a monograph for over-the-counter (OTC) antiplaque/antigingivitis drug products. After several years of meetings, the Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee, an expert panel established to advise FDA, has released a draft report of its recommendations to the agency. The report covers proposed active ingredients, directions for use, warning statements, and finished formulation testing for OTC antiplaque/antigingivitis drug products. The plaque panel is scheduled to meet again on December 2 and 3, 1998, to review the draft report and finalize its recommendations. FDA is accepting comments on the draft report.

After the panel's final report is delivered to FDA, the agency will publish it in the Federal Register, along with a "proposed monograph" (essentially, a proposed regulation) setting forth acceptable marketing conditions for these OTC drug products. The proposed monograph begins another phase of the monograph development process, during which interested parties may submit comments and additional data. Once a "final" monograph is published and becomes effective (a process that will likely take several years), OTC antiplaque/antigingivitis drug products will be required to comply with the final monograph's conditions, or else will be considered "new drugs" that require FDA approval of a New Drug Application (NDA) prior to marketing.

For further information on this subject, please contact Frederick A. Stearns (202-434-4288 or stearns@khlaw.com).