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Death of the One-Click Rule
By R.J. Lewis

On April 2, the FDA issued a wave of untitled letters to 14 major pharmaceutical companies covering 48 brands. The complaints covered a range of issues, most of them focused on the inappropriate use of Google’s text advertising. The recurring themes centered on the use of the brand name in ad copy (or URL), in conjunction with an indication, or partially communicated indication, without the presentation of fair balance and risk information.

Among other things, the letters also cited the exclusion of the generic name next to the brand name. The FDA’s clear message was that putting risk and fair balance information even “one click away” on the Internet is simply not sufficient.

Little Clarity
Unfortunately, these FDA letters leave more questions in their wake than answers. While providing some insights on what not to do, they provide little clarity on what is allowed and raise additional questions. Can marketers target “branded” reminder advertisements to users searching about their indication? On a search for “diabetes,” should advertisers deliver only nonbranded results? Are any clients taking the position that they should only target brand name searches and/or display unbranded ads on keyword searches pertaining to indications? “Our clients are split about 50/50 on this right now,” says Brian Krick, VP, Search Engine Marketing, at Razorfish, “but we are still spending time with regulatory teams, so I wouldn’t consider anything finalized yet.”

Targeting a branded ad to a disease keyword search query certainly implies the brand is indicated for that disease… doesn’t it? What about within the organic (unpaid) listings? How are they regulated? How is display impacted? The FDA has also recently cited at least one display advertiser, whose risk information was displayed on an Internet banner. To display voluminous text on a small online banner required the use of an auto-scroll box in small single-spaced font. This manufacturer’s approach, however, was deemed “almost impossible to read and comprehend in the time allotted.”

A New Mix?
How will the FDA letters affect online advertising going forward? Does this change the digital media mix of display, search, and video (pharmaceuticals are comfortable with TV)? Based on conversations we’ve had with clients, results are mixed. While many have told us the recent letters will negatively impact search and positively impact display, the verdict is still out.
Not everyone agrees that a shift from search to other formats, such as video, will occur. According to Debrianna Obara, VP, Media, at Razorfish, “The 14 FDA letters have certainly made clients and agencies alike take a hard look at their search campaigns and their ad copy. [However] pharma companies have not invested creatively in video units made for the Web and coupled with the relatively few places that offer longer-format video and scrolling fair balance, it’s unlikely that 2009 will yield an explosion of pharma video ads made for the Web.”

The FDA should share blame since specific guidance with regard to the Internet has been nonexistent for well over a decade. Let’s face it, the position that “the existing guidelines cover all media” doesn’t fly anymore. This medium is different. Media has changed. Features, ad sizes, behavioral and contextual targeting, expandable rich media, measurements of engagement, and numerous other nuances of digital media create challenges that can be replicated nowhere else in the analog world. Therein lies the power and the pitfalls of digital. Perhaps the recent wave of letters is a sign of things to come with a much better funded FDA. Let’s hope this additional taxpayer money will lead to the first formal FDA guidelines on digital advertising.

R.J. Lewis is President and CEO of e-Healthcare Solutions. He welcomes comments at info@e-healthcaresolutions.com.

Below is an expanded version of "Death of the One-Click Rule," by R.J. Lewis published in the June issue of PM360 magazine.

April 2, 2009, was the day the FDA declared war on the pharmaceutical industry's inappropriate use of Google and other search engines and defeated the long-standing belief in the “one-click rule,” which was based on the concept of “turning a page” in print. In both cases, there is no guarantee a user will either turn a page or click on an ad—but fair balance and risk information is right there for them if they do. This false belief in the one-click rule led to widespread inappropriate use of displaying fair balance and risk information just “one click” away on the Internet. With these clarifying letters, Internet advertising in the pharmaceutical industry, particularly search, has changed forever.

On April 2, the FDA issued a wave of untitled letters scolding 48 products addressed to 14 major pharmaceutical companies. The complaints covered a range of issues, most of them focused on the inappropriate use of Google’s AdWords text advertising. The recurring themes centered on the use of the brand name in ad copy (or just in the URL), not as reminder advertising, but in conjunction with an indication, or partially communicated indication, without the presentation of fair balance and risk information. An additional violation cited in many of the letters was the exclusion of the generic name next to the brand name. However, the biggest revelation to come from this series of warning letters was the FDA’s clear message that putting the risk and fair balance information even “one click away” on the Internet, which the industry has long considered to be in compliance, is simply no longer sufficient.

For many in pharmaceutical advertising this seems like common sense. However, due to space limitations and other challenges around dealing with a new medium, the general consensus—for years in the online space—has been that placing required fair balance and risk information and PI within one click of the mouse adequately addressed the DDMAC existing guidelines. Since DDMAC offers no specific guidelines pertaining to online advertising but instead points to its general guidelines covering all media, pharmaceutical companies have been left to interpret the various nuances that digital media presents.

The rationale behind the premise that search will suffer is based on a belief that search will become less effective when using only branded or unbranded creative. While branded creative works well, particularly for people searching by brand name, unbranded—while generally yielding higher click-through rates, often delivers lower engagement levels when directed to a brand.com site since users often feel “tricked” into clicking on something that looked informational but presented with a brand.com site. Is this what the FDA wants? For Pharma to “pretend” they are something they are not and to trick consumer into clicking on brand.com sites through the use of unbranded creative and unbranded URLs that redirect to brand.com sites? Perhaps instead, the trend away from “branding” and toward consumer disease education will accelerate. It seems Washington does find value in pharmaceutical companies educating the masses on a disease, as long as they leave brand promotion out of the mix.

For additional information on this topic, visit:
http://creationinteractive.com/articles/fda-warns-pharmaceuticals-about-...
http://creationinteractive.com/articles/fda-warns-pharmaceuticals-about-...
http://www.eyeonfda.com/eye_on_fda/2009/04/14-warning-letters-in-a-day.h...
http://www.e-healthcaresolutions.com/blog/index.php?blog=2index.php?blog...
http://medad.canon-experts.com/expert/bill-drummy/
http://ignitehealth.blogspot.com/2009/04/fdas-actions-speak-louder-than-...
http://ignitehealth.blogspot.com/2009/04/fdas-actions-speak-louder-than-...
http://www.nytimes.com/2009/04/17/business/media/17adco.html
http://www.clickz.com/3633348
http://www.medicalnewstoday.com/articles/146599.php
http://www.pmlive.com/find_an_article/allarticles/categories/advertising...
http://www.forums.pharma-mkting.com/showthread.php?p=12361

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