FDA Warns Pfizer On Failure To Report Drug Complaints.

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The AP (6/10, Perrone) reports that the Food and Drug Administration issued a warning letter to "Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury." In the 12-page letter, dated May 26, the FDA "cites a number of product complaints which were not reported to government regulators within the required 15 days." The letter also "demands that Pfizer submit a plan for correcting the problems within 15 business days."

The Wall Street Journal (6/10, Dooren) reports that this FDA warning letter to Pfizer is the second one this year. Two months ago, the company received an agency warning regarding pediatric clinical trials of the antipsychotic Geodon (ziprasidone). The Journal points out that the latest warning results from a 2009 inspection of Pfizer's headquarters, an inspection which the agency said was to ascertain Pfizer's compliance with reporting rules regarding adverse events after drugs are allowed on the market. Specifically, the letter said the agency discovered that some adverse-event reports were not reported until after its inspection was conducted. The drugs involved were Lyrica (pregabalin) and Lipitor (atorvastatin).

Reuters (6/10, Heavey) reports that the Food and Drug Administration has asked to meet with Pfizer to discuss the violations. In the FDA's warning letter, Ronald Pace, who directs the agency's New York office, reminded Pfizer, "FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated." For its part, Pfizer promised to work with the FDA to address and remedy the problems.