Galderma MetroGel

Executive Summary

April 8 response to FDA letter citing MetroGel broadcast ads maintains that the term "skin discomfort" does not minimize side effects of topical rosacea treatment and fairly encompasses "burning, skin irritation and dryness" ("The Pink Sheet" April 6, p. 21).Galderma also disagrees that the term "hypersensitive" is too complicated for consumers to understand. Company says, however, it will list side effects separately and include the term "allergy" in future ads. Galderma also objects to FDA comment that the ad was not adequate because it did not comply with the agency's draft broadcast guidance. "FDA has no authority to enforce a draft guidance or to cite a manufacturer for 'noncompliance' with a draft guidance"