Director of the FDA's New York Office Sent Warning Letter to Pfizer

PfizerPfizer Inc. had failed to report serious and unforeseen side effects from its drugs. FDA wrote a 12-page warning letter to Pfizer Chief Executive, Jeffrey Kindler. FDA had warned Pfizer in April over clinical trials of its drug Geodon.

In the letter dated May 26, Ronald Pace, Director of the FDA's New York office shared that it had failed to document reported problems in patients after the drugs were approved for use.

Pace wrote, “FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated”.

A meeting has been arranged between the company and the agency over the violations. Pfizer clarified that it has received the letter June 3.

The agency inspectors found system-wide lapses, when the FDA conducted a 6-week inspection of Pfizer's New York headquarters in July and August of 2009. The reports of the patients were full of serious and unexpected adverse events. They were submitted after they were identified during the FDA inspection.

FDA cited multiple examples of reporting lapses, in its letter to Pfizer.  Drugs like Viagra and similar medications cause serious visual problems, including blindness, but Pfizer did not report cases related to its drug within the agency's 15-day deadline.

General: 
Companies: 
Region: