On April 16, 2008, the FDA's DDMAC asked Pfizer to "immediately cease dissemination of violative promotional materials for Viagra" -- namely a video on the Viagra Web site that shows a group of men in a Nashville studio playing instruments and singing the following song:
"Hey fellas, check this out... First time I saw her, she set my world.. .y'know she set my world to reeling and as the years go by, for this country guy... well, we never lost the feelin'. Well, this bily goat, I played my last note...can't wait...I can't wait to get home. ..Viva Viagra!""The video," says DDMAC in its letter to Pfizer CEO Jeff Kindler, "then ends with an audio voice over that states 'Talk to your doctor about Viagra, America's most prescribed treatment for erectile dysfunction.' This video is misleading because it makes representations and suggestions about the use of Viagra for erectile dysfunction, but fails to disclose any risk information for the drug."
Kindler, in a comment to Pharmalot, said "Due to a technical error by the website, the safety information contained in a companion banner complementing the video was not displayed as instructed. Pfizer discovered the error, notified the website of the error, and our understanding was that the website corrected its error immediately."
Bull!
The video is still there without any "complementary" banner other than "Learn about the benefits of VIAGRA" at the end. The risk information is STILL missing. It's also missing when you download the video from the site and run it locally, which I have done.
Just another example of a Web 2.0 trick that can be performed right under the FDA's nose (see "Web 2.0 Pharma Marketing Tricks for Dummies").
Hello DDMAC! It's been about a week since you sent that letter. What's you next step? You end your letter by saying: "Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice."
We're prepared to wait until Hell freezes over, which may happen before the FDA ever takes such an unprecedented action.
The FDA is limp. They need to use the drug.
ReplyDeleteYou have your story wrong here. The FDA letter was not in response to the video on Viagra.com since the fair balance warning is on every page, which is FDA and regulatory compliant. Rather, there were banner ads that ran on a website and due to a flighting error only the video unit ran and not the fair balance banner. The offending site has admitted the error and given Pfizer a letter saying as much. It was a screw up, but not to the extent you are reporting.
ReplyDeleteThanks for the clarification.
ReplyDeleteHowever, maybe the FDA SHOULD cite the video on the Viagra.com site because Pfrizer encourages/enables visitors to download the video as a stand-alone video that they can play back on their computers and ipods, etc.
Just how does Pfizer "encourage/enable" vistors to download the video when the clear intent is to play and watch the video only on the website? There isn't functionality to do this provided by the product website (such as "download" etc).
ReplyDeleteAll you have to do is roll your mouse over the video window and up pops a tab that says "Download This Video". Maybe that tab is supplied by RealAudio, which I use to view videos on the Web. I suspect it is technically possible for Pfizer to make this video "non-downloadable" by RealAudio or Windows MediaPlayer, but it chose not to. Then again, it seems that Pfizer is technically challenged in the first place -- having data repeated stolen from it and its computer network violated on at least one occasion!
ReplyDelete