FDA Reprimands Pfizer for Slow Reporting of Adverse Events

Shelley Wood

June 11, 2010

June 11, 2010 (New York, New York) — The FDA has sent a 12-page letter to Pfizer, rebuking the company for not swiftly reporting serious potential adverse effects of several approved drugs, including its blockbuster statin, atorvastatin (Lipitor).

According to the May 26, 2010 letter, delays in reporting adverse events date back six years and have been growing more common: between March 2006 and December 2008, roughly 4% of more than 80 500 reported complaints were sent late to the FDA; between December 2008 and June 2009, 9% of reports were sent late. The FDA stipulates that companies pass on information about adverse drug reactions to the agency within 15 days.

Director of the FDA's New York office, Ronald Pace, sent the letter to Pfizer CEO Jeffrey Kindler, complaining that the company had not adequately documented or investigated reports of problems in patients taking some of its best-selling drugs, among them sildenafil (Viagra) and pregabalin (Lyrica), as well as Lipitor. Pace cited "serious and unexpected adverse events . . . that were not submitted until they were identified during [a July–August 2009] inspection" of Pfizer headquarters.

The agency also accused the company of misclassifying and/or downgrading reports of adverse events to "nonserious" without providing reasonable justification for doing so.

Pfizer had previously said that reporting problems stemmed from a lack of staff training with a new computerized system and had told the FDA it had implemented changes to rectify the problem. The FDA in its letter calls these changes "inadequate" and "ineffective" and says that while it acknowledges some improvements, additional factors may have contributed to the tardiness of the reports and that a "revised corrective action plan" is needed.

Pfizer has provided a statement saying the company "will work closely with the FDA to address these issues to the agency's full satisfaction. . . . We are committed to full compliance and timely and accurate submission of individual adverse-event reports."

To heartwire , a Pfizer spokesperson emphasized: "It is important to note that the FDA letter does not call into question the safety profile of any Pfizer product. The information necessary to support the safe and effective use of our products is fully disclosed in product labeling, and we stand behind the safety and efficacy of all our products used worldwide."  

As reported by heartwire , the FDA sent a similar letter to Edwards Lifesciences in April, following an FDA inspection, complaining that adverse-event reports were not being sent along to the agency within the window required by the agency.

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