PharmExec Blog

The Regulation Wars

Last Friday, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued 14 untitled letters to pharma companies as a result of online advertisements that appeared as sponsored links on search engine results pages. There were already plenty of guidelines on marketing to consumers being enforced by PhRMA, but now comes a crackdown on Internet marketing from FDA. What’s going on here?

Regulatory guidelines require pharma to attach related risk information to all. There is, however, one exception to this rule: Reminder ads or ads that provide consumers with the drug’s name, but no indication for use—because it’s assumed that the consumer is familiar with the drug. So where is the line drawn for pharma?

It turns out that the line is drawn with a cursor pointed to a link reached with the click of a mouse. The ads that were subject to the warning letters were not considered reminder ads, and thus showed up on FDA’s radar. We found a few examples of these letters posted online, with some interesting opinions by Porter Novelli Director of Global Health Care Peter Pitts. Check it out on his blog,

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  1. Posted April 6, 2009 at 4:18 pm | Permalink

    Let’s hope marketers don’t over react to this by retrenching on all online efforts. Fair balance and risk information can clearly be communicated via online display advertising, and has been for years.

  2. Blogreader
    Posted April 6, 2009 at 10:20 pm | Permalink

    What about ads on health sites???

    That seems more problematic.

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