A Warning Letter was posted by CDER’s DDMAC on Friday, September 26 that was sent to Shire Pharmaceuticals regarding a Web promotion and a YouTube video for Adderall XR. While normally Warning Letters are not featured here except in a quarterly roundup, this one has significance since it involves a foray into YouTube by a pharmaceutical company promoting a product. Again, the lesson here is that it is the message, not the medium, that trips the regulatory tripwire.
According to the FDA, there was both a webpage and a video promoting Adderall XR, both of which were said by the agency to overstate the efficacy of the product and citing the video for omitting important risk information. As well, the webpage was said to broaden Adderall XR’s indication beyond that approved by the FDA. There is nothing in the Warning Letter to suggest that the use of video in and of itself to promote is a problem, merely the omission of risk information.
Here is the text of the statements made by Ty Pennington in the video (no longer up):
Now once I got on medication it’s just amazing the transformation I made. I -It literally changed my life, and gave me the confidence to achieve my goals, like being an artist. As a kid, I never could have imagined I could do it. But with the medicines like Adderall XR, it’s truly a transformation. I mean talk about an Extreme Makeover, I’m like living it. Now growing up with ADHD can be a little difficult. It’s not easy to communicate with people, including your own family. So you become kind of alienated. You feel like you’re different, and you don’t really fit in. And that, well, can kind of cause you to feel different, and nobody likes to feel different. So as someone who has had ADHD, and is overcoming it, proper treatment has truly changed my life and made an amazing difference.
Needless to say the claims that are made in bold face are claims that, had they been made in a print ad or a television commercial, would have had the same result of a warning letter, because the FDA felt that stating that the product and "transform lives" or build up confidence is quite simply beyond the indication for the drug. It is the message, not the medium.
According to the FDA, the video stated no risk information. That is an omission.
Companies still leery of the use of video should perhaps start with unbranded messages that are about disease awareness. But the existence of a warning letter aimed at a YouTube promotion should not influence the use of YouTube any more than a warning letter for a print ad that simply does not address regulatory parameters would stop print ads.