A little delayed on my part, but thanks to Mark Senak of EyeOnFDA for the tweet-alert that notified me of Shire’s Warning Letter (PDF file) from DDMAC last Friday (SEP 26th — my birthday!), regarding their promotion of a YouTube video for Adderall XR. Here’s an excerpt of what was stated in the letter:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a webpage and a video testimonial featuring Ty Pennington posted on youtube.com by Shire Development Inc. (Shire) for Adderall XR® Capsules (Adderall XR). Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use. Additionally, the webpage broadens the indication for Adderall XR by suggesting uses that have not been approved by FDA… The webpage and video raise significant public health and safety concerns through their overstatement of efficacy and omission of important safety information.

This is the first case of a DDMAC Warning Letter that I know of which specifically targets a video on YouTube, indicating that the the FDA is definitely paying close attention to these new and emerging distribution channels. However, while this case does specifically reference YouTube, it is important to note that it’s NOT YouTube itself or the medium/channel that is the issue, but rather the content. In other words, the online video comes under the same standard of regulation and scrutiny as traditional mediums, such as print or DTC television ads. Mark Senak very succinctly sums it up in the following sentence: “Again, the lesson here is that it is the message, not the medium, that trips the regulatory tripwire“.

You can read more commentary about this case here or, additionally, John Mack — over at Pharma Marketing Blog — also has an interesting interpretation of this case, as usual. Here’s a quote:

By the time the FDA issues a warning letter about a DTC ad that violates FDA regulations — as it did on September 25, 2008, for a video testimonial featuring Ty Pennington posted on youtube.com by Shire — the cow has long left the barn… The Ty Pennington Adderall XR video can no longer be found on YouTube, which proves that Web 2.0 Tricks work! (see “Web 2.0 Pharma Marketing Tricks for Dummies“).

With the rise of pharma related YouTube channels, this should be an interesting space to watch. And whatever the case, if you’re thinking about launching healthcare related videos online (e.g. via YouTube or other video sharing sites), I don’t think this Warning Letter should be a deterrent for using the medium whatsoever.  As stated so eloquently by Mark Senak:

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.