FDA Was Wrong About Google Functionality

I didn't say very much about the use of Google text ads in the Regulatory Alert that I released last week about the FDA space-limited risk & benefit presentation guidance. Partly, that's because I'm working on an article about Google text ads that updates the chapter in my primer.

There is, however, one extremely important item to point out. FDA got sitelinks wrong. I don't mean that I disagree about the FDA's view on the use of sitelinks. I mean they don't understand the technology, and what they say in the guidance demonstrates that.

The FDA guidance recommends using sitelinks to include some risk information that the FDA says people must include if they are presenting product benefit information (and the product name). The example they give is:


In this example, the benefit information "For severe headache from traumatic brain injury" requires corresponding risk information to be balanced.

The FDA accomplishes that risk presentation via the various sitelink descriptions "Potential for brain swelling," "Life-threatening drop in heart rate," etc. Importantly, the words in the sitelinks themselves "Boxed warning," "Warning," and "Risk information" do not themselves constitute risk information, just links to risk information. Consequently, those links in themselves do not suffice to provide the risk information.

The first problem with this is that FDA is assuming that a product manufacturer can guarantee that their ads have the sitelinks and the link descriptions appear when they run the ad. But you don't have that control.

Google does not guarantee that sitelinks will ever appear. In fact, Google's page dedicated to sitelinks in paid search campaigns, includes a section header called, "Why your sitelinks aren't showing," and the first sentence under that header reads, "Keep in mind that your ads won't always show sitelinks."

That's a problem because if your ad is running with benefit information presented in the body of the ad, the ad requires the risk information to meet the fair balance requirement. If your ad displaying the benefit information does not include the sitelinks, then the ad would violate the fair balance requirement.

So, if the maker of HeadHurtz were to actually run the ad that the FDA provides as an example, there's a significant chance that the ad would actually appear as follows:


This ad would definitely be violative because as we learned in 2009, and as FDA reiterates in this guidance, if the product name and benefit information is presented, then FDA requires that some risk information be presented at the same time with comparable prominence as the benefit information.

So following the FDA's provided example could result in violative promotional activity. Moreover, even if the sitelinks appear, there's a chance that the sitelink description would not appear. But again, the sitelinks provided in the example ("Warning," etc.) do not in themselves provide risk information. So, just providing the sitelinks would not meet the fair balance requirement.

Further compounding the problems with the FDA's example is that the order and number of sitelinks provided varies without complete control by the advertiser. So, if all four sitelinks were not provided, there's a chance (based on FDA's guidance) that the advertiser might not be complying the fair balance requirement because FDA might deem it necessary to provide ALL four sitelinks to meet that requirement.

As if these problems were not enough, there's one more difficulty: mobile devices. If this ad were enabled for display on mobile phones (which is not required for Google ads but is encouraged), then you would definitely not have all four sitelinks presented, and none of the descriptions of the sitelinks would be presented.

So, the sample ad presented by the FDA could definitely not run on mobile phones, but of course, mobile access to the Internet is exploding, and in fact, some people (hint: me) believe that providing information via mobile devices is even more important than doing so via desktop.

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