Judgment Day For The FDA, Pfizer

Next Wednesday, Feb. 16, painkillers go on trial. The big question: Will the jury be tough enough? A panel of academic scientists--who have not yet been publicly named--will meet to advise the U.S. Food and Drug Administration on the safety of Cox-2 inhibitors such as Celebrex, Bextra and the withdrawn Vioxx. They will also delve into the safety of older anti-inflammatory medicines such as Aleve and Motrin. The task is so difficult that the FDA has allotted three days for the work, a clear sign of controversy. The last similar meeting was on the safety of breast implants. The three-day discussion will provide a climax to a debate about drug safety that began when Vioxx was pulled from the market for doubling the risk of heart attacks and strokes at high doses over long-term use. It will be an especially important meeting for Pfizer (nyse: PFE - news - people ), which makes Celebrex and Bextra. The meeting is likely to determine the future of those drugs--including whether they have a future at all. The discussion may also have an impact on Pfizer's potential liability. Even if Celebrex and Bextra don't make it through the meeting, Pfizer could look like a winner to investors as long as it doesn't face a massive liability cloud like the ever-ballooning diet-drug litigation that has weighed on smaller rival Wyeth (nyse: WYE - news - people ) for years.

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