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.
