Thursday, June 17, 2010

Pfizer’s Adverse Event Reporting Warning Letter: Those Who Don’t Learn History…

Maybe its summer re-run season, or the fact that the hottest new movies are Karate Kid and the A Team, but we are feeling a lot of déjà vu lately.

An FDA advisory committee to review the safety profile of Avandia? We’ve definitely seen that before. A big pharma company in the hot seat for manufacturing/quality control issues? This time its J&J, but Schering-Plough and Wyeth and Warner-Lambert have all seen this movie before. (Hmmm…Though none of those three companies is independent anymore…)

But what really sealed the deal was this item: Pfizer getting a Warning Letter from FDA citing the company for failure to forward adverse event reports to the agency in a timely fashion. Not just the letter, but—as we noted in The Pink Sheet—the fact that the letter leaked to the media shortly after receipt by the company, and hence got much more media attention that it might otherwise have received.

We couldn’t shake the strange feeling that we had seen this one before too. It took some digging in the archives, but we were right. In April 1996, Pfizer got a letter from FDA citing the company for failure to submit adverse event reports to the agency in a timely fashion. Not only did Pfizer get the letter, but FDA leaked it right away to the AP—the exact same outlet to get the letter this time around.

They say history doesn’t repeat itself, but this is as close as it gets. Different products, but same company, same issue, and same attention getting strategy by the agency, 14 years later.
Okay, so what does that tell us, other than that The Pink Sheet’s archives are an incredible resource, and that FDA’s communication tactics are tried and true?

Well, first off there is some sort of lesson in this for Pfizer. Yes, 14 years is a long time and it is ridiculous to draw any conclusions from that coincidence about some sort of corporate history of sloppiness in adverse event reporting. Heck, the latest letter focuses computerized systems that apparently didn’t work as well as Pfizer hoped; the very idea of computerized adverse event reporting was new in 1996.

But still, it does say something about Pfizer’s failure to learn from experience. After all, FDA used the exact same playbook on this issue that it followed 14 years ago, by coincidence or otherwise. For the same company to be the same target when FDA decided to set an object lesson is at least a little bit embarrassing.

There is a more important implication for everyone else. Today, just like 14 years ago, the point of FDA’s strategy is clear: the agency wants to get everybody’s attention on the issue of adverse event reporting. Picking on Pfizer is one thing, but the purpose of the leak is to make sure other companies review their systems and correct any similar problems. It is much easier to leak one letter than to inspect every pharma company for similar issues.

Here’s a bit more history. At the start of 1999, FDA sent two more Warning Letters, citing Novartis and Berlex for failure to submit timely adverse event reports.

That suggests that most manufacturers got the message when Pfizer was warned, and that FDA was willing to give them a bit of time to adjust. But, in FDA’s eyes at least, not everyone got the message quickly enough.

We’ll see if that piece of history repeats this time around.

1 comment:

Anonymous said...

this is so retarded.... the letter was posting anyway so what does a letter being released to media outlets five days ahead of schedule have to do with the price of tea in China... Mikey, pls stop stretching things because it shows how short sighted you and this rag really are. If FDA wanted this leaked it would have released the 483 a year ago, etc. This is a year old case... end of story !!!!!