GlaxoSmithKline got a trip to the FDA woodshed for failing to regularly report post-marketing data it was gathering on the diabetes med Avandia. GSK failed to include updates on as many as 18 different trials in its annual reports to the agency on that med. The agency rebuked GSK, ordering the company to get its act together pronto.
A Glaxo spokeswoman called the missing reports "inadvertent omissions." But that's just the point, the FDA said. The company lacks a system for making sure the right data gets to the FDA at the right time, the agency said. So what other data on which other drugs is also going unreported? "Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the post market reporting for your firm's other FDA-approved drugs may exist," the letter states. In fact, the FDA only discovered the missing reports when it conducted an audit last fall, in the wake of safety concerns about the diabetes treatment.
And the warning letter isn't a bureaucratic exercise, either--just ask Pozen, one of GSK's development partners. Last fall's FDA legislation gave the agency new post-marketing oversight powers. GSK's letter states that the agency could deny approval of any new Glaxo products until the company corrects its reporting snafus. Speculation that this provision might affect a GSK/Pozen product Treximet sent the smaller company's stock tumbling Tuesday.
- find the FDA warning letter
- read the article in the International Herald Tribune
- see In Vivo's interpretation of the warning
- check out the story in the Wall Street Journal
- get the Pozen news in Forbes
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