FDA warns Pfizer for not reporting side effects
Thu Jun 10, 2010 6:59am EDT
WASHINGTON (Reuters) - The U.S. Food and Drug Administration has warned Pfizer Inc for failing to quickly report serious and unexpected potential side effects from its drugs already on the market.
In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company's top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.
The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA's letter that was released by Pfizer on Wednesday.
Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.
"FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," Pace wrote.
Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Pfizer said it received the letter June 3.
The FDA conducted a 6-week inspection of Pfizer's New York headquarters in July and August of 2009, where agency inspectors found system-wide lapses at the world's largest drugmaker.
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 fix the problem "have been shown to be ineffective," he added.
In a statement, Pfizer said it would work with the FDA to satisfy the agency "and to assure optimal surveillance and reporting of post-marketing adverse events."