Ketek — The FDA Perspective

To the Editor: In response to the article by Ross in this issue of the Journal,1 we wish to clarify how the Food and Drug Administration (FDA) reviewed Ketek (telithromycin). Although there are other statements or suggestions in the article that also need clarification, we address a few key points in the limited space available here. First, safety concerns were identified by the FDA early in the review process and taken very seriously throughout four years and three review cycles. The FDA's approval decision followed a careful review of the safety data submitted, including foreign postmarketing adverse-event reports that . . .