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FDA Warning Letters for Pharma Search Marketing Advertising

Guest Blogger

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On March 26, 2009, DDMAC issued warning letters regarding paid search ads (referred to by FDA as "sponsored links") to 14 pharmaceutical companies. These 14 letters addressed the sponsored links for 48 individual drug advertisers. While not directly addressed in these warning letters, it’s important to note that DDMAC also issued an informal warning to one pharma company regarding organic search listings. Until now paid search advertising had been a relative "Wild West" in terms of rules and regulations… or more specifically, the application and enforcement of those rules. With the recent issuance of these warning letters, we now have a blueprint for what will be allowed by DDMAC, and we know the FDA is actively monitoring search engine listings.

Why Were Letters Issued?

If you are a product manager or marketing manager, you may have already read through the warning letters and gleaned your own information. At Intouch Solutions, we have reviewed each letter in detail and have identified the 3 main reasons we believe these letters were issued:

Let’s look at each of these individually.

1. Omission of risk information

The FDA declares in all letters that the cited search ads make specific claims of indication without providing the required risk information. In the LUCENTIS® ad that was cited in a letter to Genentech, there is a clear statement about the efficacy of LUCENTIS®. However, there are several risks for adverse side effects that are not stated in the advertisement.

2. Inadequate communication of indication

In these cited ads, there are very brief indication statements that may be incomplete or misleading. For example, while this advertisement for FENTORA® has a brief statement of indication ("treating breakthrough pain in patients with cancer"), it does not accurately define the patient for which FENTORA® is actually indicated.

3. Failure to use required established name

This violation is fairly clear and can be easily addressed. When using the product name, it is required that the fully prescribed name is displayed. In the examples above, both advertisements are in violation of this regulation because they do not use the generic name with the branded name. Rather than just saying "Lucentis®" each time the brand name is used, "LUCENTIS® (ranibizumab injection)" must be used.

What are the Implications for Search Engine Marketing?

As pharmaceutical search marketers, we are no longer living in the Wild West. The bar has been set by DDMAC. At Intouch Solutions, our in-house Search Engine Marketing team specializes in search engine optimization and pay-per-click advertising for pharma companies. There were no real surprises from DDMAC, but we have enhanced our best practices to ensure the issues outlined are addressed, and we will be making recommendations to all of our clients. We still believe strategic goals can be augmented with paid search advertising — even with these regulations in place.

For additional information, contact your Intouch Solutions representative, or email us at


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