The Food and Drug Administration said it asked Pfizer Inc. (PFE) to resubmit a large number of adverse-event reports last year involving the company’s smoking-cessation treatment Chantix.
The FDA said in a statement posted on its website Thursday that it became aware that Pfizer and a few other manufacturers the agency wouldn’t name were submitting some adverse-event reports through “improper” channels.
There are two ways companies report adverse events to the FDA that might be product related. One way is through periodic summary reports, and another, faster way goes through a process that allows the reports to be quickly entered into FDA’s adverse event reporting system or AERS. Typically reports related to side effects that are already discussed on a drug’s label can be submitted through periodic safety-summary reports while reports that are unexpected or fatal are required to be filed as so-called 15-day reports that are filed into FDA’s AERS system.
