Pfizer received a warning letter last month from the FDA because of the company’s failure to report complaints promptly. The agency warned Pfizer about its failure to promptly report complaints associated with its drugs that may have involved serious injury. According to the warning letter, Pfizer repeatedly failed to submit product complaints to the FDA within the required 15-day regulatory scheme. In some cases, Pfizer failed to report adverse events altogether, including reports of serious side effects with the cholesterol drug Lipitor and the anti-seizure drug Lyrica. These concerns were initially raised by the FDA following an inspection that concluded in August 2009. Let’s hope for safety’s sake that Pfizer will comply with the regulatory scheme in the future.
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