The U.S. Food and Drug Administration sent a 12-page warning letter to Pfizer (NYSE: PFE) for failing to report certain serious potential side effects from its drugs, including Viagra, Lipitor and Lyrica, which are already on the market.
The company’s failure to report side effects of some of its drug date back to 2004 and have grown in recent years, according to the FDA’s letter which was released by Pfizer.
FDA New York office director Ronald Pace told Pfizer in a letter dated May 26th that the company had not properly documented and investigated problems in patients after drugs were approved for use by the public. Pace asked the company’s CEO to arrange a meeting between the company and the agency over the violations.
The FDA conducted a six-week inspection of Pfizer’s headquarters in New York in July and August of 2009, where the agency’s inspectors found several system-wide lapses at the company.
The patient reports “contained serious and unexpected adverse events… that were not submitted until they were identified during the FDA inspection,” Pace wrote. Efforts to resolve the problem “have been shown to be ineffective,” he added.
Pfizer said in a statement that it would work with FDA to satisfy the agency “and to assure optimal surveillance and reporting of post-marketing adverse events.” Pfizer also said that individual reports are just one part of its overall monitoring of the drugs that it sells and that the company “believes we provide complete and accurate data to determine the benefit and risk profile for all of our medicines, and to enable their safe and appropriate use.”
