FDA rebukes Pfizer's handling of blockbuster drugs' serious adverse events

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.

Steve - the delays and downgrading of serious adverse events should not surprise anyone. What should surprise us is the FDA's very public rebuke.