14 June 2010

FDA Warns Pfizer on Reporting Failures

The Wall Street Journal

The Food and Drug Administration warned Pfizer Inc. about its failure to properly follow the agency's rules on reporting adverse events involving products.

The agency sent Pfizer a letter dated May 26 that stemmed from an FDA inspection at Pfizer's New York headquarters from June 29 through Aug. 10, 2009. The letter outlined about a dozen violations of agency rules.

The warning letter is the second issued by the FDA. In April, Pfizer was warned about "significant violations" involving pediatric trials of its antipsychotic drug Geodon. Until the issues cited by the FDA in its warnings are resolved, the FDA can hold up approval of any products under review.

The May warning letter stemmed from last summer's inspection of Pfizer's headquarters. The FDA said the inspection was conducted to determine the company's compliance with postmarket adverse-event reporting rules, which require drug manufacturers to report potential problems it receives involving their products to the agency within a certain number of days.

The FDA said it found some reports of adverse events involving Lyrica and Lipitor that weren't reported to the agency until after the inspection found the reports.

One reporting requirement states that companies must report serious and unexpected adverse events to the agency within 15 calendar days after receiving such reports.

The agency said the company failed to submit some 15-day reports involving visual disturbances associated with the erectile dysfunction drug Viagra and downgraded some of the reported events to "nonserious without reasonable justification."

In a statement Wednesday, Pfizer said it would continue to work closely with the FDA "to address these issues to the agency's full satisfaction and to assure optimal surveillance and reporting of postmarketing adverse events."

Along with citing failures to properly follow adverse-event reporting rules, the FDA said the company failed to conduct an immediate investigation after receiving reports of prescription drug-sample thefts.

Pfizer spokeswoman Kristen Neese said, "It is important to note that the FDA letter does not call into question the safety profile of any Pfizer product."

The letter outlines longstanding problems with Pfizer's ability to properly report adverse events involving its products. The FDA said it issued inspection reports in 2004 and 2006 "for similar postmarking drug-adverse experience violations."

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