Abstract
The FDA and the Case of Ketek Since the FDA approved the drug Ketek (telithromycin), concerns have arisen about both safety and fraud. Dr. David Ross writes that there are lessons to be learned from an examination of the events surrounding the approval of this product. Dr. David Ross discusses the FDA review process for the antibiotic Ketek, problems with data integrity, and the “culture of approval” at the FDA. Dr. Ross is a clinical assistant professor at George Washington University School of Medicine and Health Sciences, Washington, D.C., and a former medical reviewer for the FDA.
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