PharmExec Blog

Is FDA Watching YouTube?

Two weeks ago, Shire received a warning letter for posting a sponsored testimonial on YouTube without including risk information. Shire was very open when I called them up and admitted that the video was posted by accident and immediately removed when it was brought to the company’s attention.

While I’m not 100 percent positive, it looks like this might have been the first time FDA actually name-dropped a social networking service in a warning letter. Which poses the question: Is FDA watching YouTube, and what does this mean for pharma?

Ignite Health’s Fabio Gratton told me that this ramification could go one of two ways. Pharma could view it as the feds are now treating YouTube with the same degree of importance as television and other media outlets, thereby validating the online service. Or it could scare pharma away from posting videos on YouTube, because that could warrant a warning letter.

So where does FDA stand?

I sent an email to FDA spokesperson Felicia Stewart with one question: Are you guys watching YouTube for pharma ads?

She missed the deadline for the article, but lo and behold, this morning I got a nice, concise answer from the feds.

DDMAC has been and continues to monitor the many vehicles that companies use to promote their prescription drug products. Our monitoring includes magazine ads, TV ads, promotional exhibits at medical conferences, Internet, sales brochures, journal ads, and consumer mailers and brochures. Internet monitoring includes promotion done by or on behalf of drug companies such as companies’ own product Web sites and their placement of promotion on others Web sites. The action addressing promotion by the company on YouTube is one example. Another example is the action addressing Pfizer’s promotion on for Viagra.

There you have it. FDA is watching YouTube, and boy, do I wish I was the guy or gal being paid to troll the Web all day looking for errant pharma ads or remixes of the Rozerem beaver singing the Tay Zonday classic “Chocolate Rain.”

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  1. Posted October 15, 2008 at 10:03 am | Permalink


    Very interesting. My feeling is let’s not make a mountain out of a molehill. Clearly, FDA is going to monitor any media channel pharma is using to promote its products. It’s important to focus on content, not context when evaluating the regulatory risks of specific marketing initiatives. For more on this topic, please see my blog post about the Shire warning letter here:

  2. Posted October 18, 2008 at 10:45 am | Permalink

    As a matter of policy, just to avoid some unintended consequences of what employees might put of these social networking sites, I suggest that their IT departments block access from computers inside the organization’s network.

  3. Posted November 12, 2010 at 6:42 am | Permalink

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  5. Posted February 18, 2011 at 3:09 am | Permalink

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