Paid Search Compliance POV

April 9, 2009 Analyst: Bruce Grant, SVP/Business Strategy

EXECUTIVE SUMMARY
FDA’s recent mass enforcement action telegraphs clearly that it considers paid search links to be advertisements, subject to all of the regulatory requirements applicable to prescription-drug advertising, including the requirement that ads containing both the product name and any representation about the product must disclose material risk information in the body of the ad itself, not “one click away.” Since this disclosure is not possible within the extreme brevity of a sponsored search link, Digitas Health advises pharmaceutical marketers to construct sponsored links either as “help-seeking” ads, referencing the indication, but not containing the product’s name, or as “reminder” ads, containing the product name but making no representations about the product.

BACKGROUND
On April 2, FDA’ s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued letters to 14 leading pharmaceutical companies charging a wide range of violations in paid search links. The 48 separate brands were all cited for inadequate communication of indication, failure to use the generic name — and, most crucially, omission of risk information. This last charge came as a particular surprise to many pharma marketers. While link copy can, in most cases, be crafted to adequately state the indication and include the generic name, the extreme brevity of this medium (25 characters for headline and 70 for body copy) makes communication of the major risks — often referred to as Important Safety Information (ISI) — effectively impossible for virtually all prescription drugs. Up to this point, marketers and their agencies had relied on the so-called “One-Click Rule,” which posited that presentation of the ISI on the linked-to page constituted adequate compliance with the requirement of risk disclosure. The letters, however, make it abundantly clear that this “rule” had, in fact, been only a theory, with which FDA takes unambiguous exception. In the words of one letter — We note that this sponsored link contains a link to the product’s website. However, this is insufficient to mitigate the misleading omission of risk information from this promotional material. 1

RELEVANT FACTS
FDA has repeatedly stated over the last decade that it believes the regulatory principles developed for advertising in print and broadcast media are adequate for, and applicable to, the regulation of pharma-sponsored Internet communications. Indeed, it has repeatedly declined to issue any Internet-specific guidance documents. Fundamental to these long-established principles is the requirement that — “…promotional materials [that] include the name of the drug product [and] include indications or other representations or suggestions relative to the drug product…are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to the consequences that may result from the use of the drug as recommended or suggested by the materials.” 2

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The only exceptions to this requirement are — 1. Reminder Ads, which give the drug's name but not the drug's use, on the assumption that the audience knows what the drug is for and need not be told. Reminder ads do not require risk information, because they do not discuss the condition treated or how well the drug works. However, reminder ads for drugs with boxed warnings are not permitted under FDA regulations and are discouraged in DTC broadcast and print media under the PhRMA Guiding Principles. 2. Help-Seeking Ads, which describe a disease or condition but do not recommend or suggest specific drugs. Help-seeking ads may include a drug company's name and may also provide a telephone number or URL for more information. Help-seeking ads are regulated, not by FDA, but by the Federal Trade Commission.

RECOMMENDATIONS
Digitas Health believes that, while pharmaceutical marketers can clearly no longer sponsor search links containing a product name in conjunction with a claim, they can still lawfully sponsor links either in reminder form, e.g. — LUMENEX® (spurioustatin sodium) Official Site www.lumenex.com or in help-seeking form, with a non-branded URL e.g. — Do you know your risk for heart attack? Learn about a new treatment for high cholesterol www.heartbeat.com

IMPLICATIONS
Left unanswered in these letters is the question of whether serving a branded, reminder-form sponsored link in response to a search on a condition-related term would be considered violative by FDA. Also unanswered is whether an unbranded, help-seeking form may link directly to a branded product site, via an unbranded “vanity” URL or whether it must first link to an unbranded site or landing page. While these matters must be regarded as speculative, we take note that the simultaneous issuance of 14 letters on a single topic was acknowledged by FDA as effectively constituting a major policy statement — “While conducting our routine monitoring and surveillance activities, we noticed regulatory violations occurring in sponsored link promotion across multiple drug companies and therapeutic areas. In response, we developed and issued multiple letters on multiple drugs simultaneously to prompt the correction of the violations…and to maintain a level playing field for regulated industry.” 3 Given the opportunity to address the issue of paid search definitively, Digitas Health believes that FDA’s silence on these more recondite issues was considered — especially in light of their historic reluctance to enunciate policies unique to the Internet. We do not envision FDA engaging these questions in the near-to-mid term. This POV is a publication of Digitas, Inc. and is intended to provide information and our interpretation of recent regulatory developments. This POV should not be construed as legal advice or a legal opinion on specific situations.
1 2

DDMAC Untitled Letter to Johnson & Johnson Pharmaceutical Services, LLC. NDA#21-976; MACMIS#17310, 4/2/2009. 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)

April 9, 2009

Paid Search Regulatory Compliance POV

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3

The Pink Sheet Daily, April 6, 2009.

April 9, 2009

Paid Search Regulatory Compliance POV

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