In a stinging, 12-page letter, the FDA has scolded Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra, and neglecting to tell the agency about missing samples, some of which may have been stolen, although the FDA wasn’t always informed promptly. The May 26 warning was issued in response to a 6-week audit of Pfizer’s New York headquarters last summer.

The delays in reporting adverse events go as far back as 2004 - and accelerated more recently. About 4 percent of 80,560 reports weren’t filed with the FDA on time between March 2006 and December 2008 compared with 9 percent from December 2008 to June 2009. For instance, Pfizer failed to report cases concerning Viagra and serious visual problems within a 15-day deadline “by misclassifying and/or downgrading reports to non-serious without reasonable justification.” Pfizer faces litigation over Viagra and visual side effects. Pfizer was also granted waivers offering more time to file reports for drugs as Bextra, but was still late making those deadlines. And 33 percent of reports for AEs regarding 10 specific meds, such as metformin, and required to be filed with five days were late.

“FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated,” wrote Ronald Pace, who heads the FDA’s New York office. The patient reports “contained serious and unexpected adverse events…that were not submitted until they were identified during the FDA inspection” and efforts to fix the problem “have been shown to be ineffective.” The FDA noted Pfizer received warnings about the same problems in 2004 and 2006, and also failed to take corrective actions at the time. [Editor's note: We have seen the letter, which is not yet available on the FDA web site, but we will provide a link as soon as possible].

For its part, Pfizer issued a statement insisting it provides “complete and accurate data” to determine the benefits and risks of its drugs, although that’s not the same thing as saying all adverse events are reported on time. The drugmaker then promised to ” assure optimal surveillance and reporting of post-marketing adverse events…We are committed to full compliance and timely and accurate submission of individual adverse event reports.”

But how did this happen? The FDA wrote that Pfizer initially blamed a new computer system to handle AE reports and that staff were not properly trained. In fact, only six of 63 offices worldwide were trained - and some weren’t even trained on time. In September, Pfizer told the agency it would update user manuals and improve staff training. Perhaps some of the better trained staff were among the thousands laid off?

In any event, the FDA wrote that Pfizer’s attempts were “inadequate.” Although Pfizer insisted its reporting improved after May 2009, the agency noted there was nothing to back up the assertion. Now, the drugmaker has just 15 days to fix the problems or explain why it will take longer. Pfizer must also give the FDA a plan for how it will get this done - and if things don’t improve, the drugmaker could face penalties, such as delays in drug approvals.