Sanofi comments on otitis media guidance

Executive Summary

Sanofi-Aventis was the only company to submit comments on FDA's Acute Bacterial Otitis Media draft guidance. The company initiated its own pediatric-specific program in ABOM in 2002, and its comments, the company said, "come from practical and recent experience." Sanofi cautioned that there are challenges in conducting superiority trials in that the enrollment of patients with sufficient morbidity to demonstrate treatment effect in placebo-controlled studies may not be possible. Sanofi also said the guidance should make clear the relationship between criteria for enrollment and outcomes, and that the methodology to manage the uncertainty in clinical diagnosis in large studies, where tympanocentesis on all patients cannot be performed, needs to be addressed