Safety Information and Search POV

July 27, 2010 Analysts: Mark Pappas, Manager, SEO Dale Cooke, VP/Director, Regulatory Review

EXECUTIVE SUMMARY
To avoid a supposed ´duplicate content penalty,µ some agencies recommend that pharma marketers take measures to conceal risk information from search-engine algorithms. Because no such penalty, in fact, exists ³ and because some of these measures (e.g., embedding the information in images) can both negatively impact actual search performance and raise substantial regulatory risk exposure, Digitas Health recommends that risk-concealment measures be avoided and that the full Important Safety Information be included, in HTML text, on every Web page requiring fair balance.

BACKGROUND
Websites for pharmaceutical brands are required by Federal regulation to present a fair balance of risk and benefit information. Most pharmaceutical companies meet this requirement by displaying the key risk information, often called the ´Important Safety Informationµ or ISI, on all pages of their brand website.1 Because the ISI typically represents a large volume of content, displaying this same content on every page of a site has raised concerns among pharma marketers about being penalized by Google·s search algorithm for ´duplicate content.µ Fear of this penalty has, in turn, led some pharma marketers to ´hideµ repetitive ISI content from search engines in various ways, including embedding the ISI text in an image where it cannot be machine-read.

RELEVANT FACTS
According to Google, fear of repeated ISI text triggering a downgrading of search ranking is unfounded ³ ´There's no such thing as a ¶duplicate content penalty.· At least, not in the way most people mean when they say that.µ 2 ´Duplicate content on a site is not grounds for action on that site unless it appears that the intent of the duplicate content is to be deceptive and manipulate search engine results.µ 3

IMPLICATIONS
Search Performance Google now takes page load speed into account in their ranking algorithm.4 An image large enough to accommodate all of the ISI text could considerably lengthen page load time ³ potentially triggering the very degradation in search ranking that it seeks to avoid ³ and create a poor user experience. Regulatory Compliance Using an image also poses regulatory risks. If, for any reason, the image does not load properly, no risk information would be displayed on the page, raising exposure to FDA enforcement action. This risk is not merely hypothetical. Pfizer, for example, received a letter in 2008 for an online video promoting Viagra where the risk information was displayed in a banner separate from the video. When displayed on CNN.com, the banner displaying the risk information failed to load properly, and FDA issued a Warning Letter for omission of risk.5

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Risk can also arise when consumers print out materials from websites (such as, ´Questions to Ask Your Doctorµ) and take them to a physician. Browser settings, not under the control of marketers, often omit printing of images, resulting in printouts clearly sponsored by the pharmaceutical company but lacking fair balance. In light of the FDA·s recently announced ´Bad Ad Program,µ which aims to enlist physicians to report violative materials, the risk associated with this eventuality are substantially heightened.6 The most serious risk, however, is that any measures to conceal risk information from search engines, while at the same time actively optimizing the visibility of benefit information, could ³ and, in today·s aggressive regulatory climate, most probably would ³ be construed by FDA as intentionally presenting risk information in a manner that is not ´reasonably comparable with the presentation of information relating to effectiveness of the drug,µ as required by 21 CFR 202.1(e)(7)(viii). Indeed risk minimization or omission has been one of the most frequent triggers of recent DDMAC enforcement.

RECOMMENDATIONS
To avoid potential negative impact on search rankings associated with image-embedding and to ensure regulatory compliance, Digitas Health recommends placing the Important Safety Information as HTML text on every page in which the brand is mentioned.

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Though not universally adopted, this practice appears to meet the criteria set out in the Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion regarding the ³Accuracy and Comprehensiveness of Risk Information,´ page 14. Draft guidance released May 2009, last accessed on July 27, 2010, from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm. Such a presentation of the risk information does not necessarily suffice to meet the FDA¶s requirement that the ³net impression²i.e., the message communicated by all elements of the piece as a whole,´ Guidance page 4. For a recent example of a piece that included the full ISI, but where FDA decided that the net impression nonetheless did NOT convey significant risk information, see MACMIS # 18396, letter sent April 14, 2010, to Novartis Consumer Health for an email promoting Voltaren Gel (diclofenac sodium topical gel). Letter last accessed on July 27, 2010 from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationL etterstoPharmaceuticalCompanies/ucm197224.htm

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http://googlewebmastercentral.blogspot.com/2008/09/demystifying-duplicate-content-penalty.html http://www.google.com/support/webmasters/bin/answer.py?answer=66359 http://googlewebmastercentral.blogspot.com/2010/04/using-site-speed-in-web-search-ranking.html Warning letter issued on April 16, 2008, last accessed on July 27, 2010, from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationL etterstoPharmaceuticalCompanies/ucm049750.htm For information about the Bad Ad Program, see http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/uc m209384.htm

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July 27, 2010

Safety Information and Search POV

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