100 East Penn Square|Philadelphia, PA 19107© 2009 Digitas Health phone (215) 545-4444 |fax (215) 545-4440 |digitashealth.com
Paid Search Compliance POV
April 23, 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 thatads containing both the product name and any representation about the product must disclose material risk informationin the body of the ad i
tself, not “one click away.” Since this disclosure is not possible within the extreme brevity of asponsored 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 leadingpharmaceutical companies charging a wide range of violations in paid search links. The 48 separate brands were allcited 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 craftedto adequately state the indication and include the generic name, the extreme brevity of this medium (25 characters forheadline and 70 for body copy) makes communication of the major risks
—
often referred to as Important SafetyInformation (ISI)
—
effectively impossible for virtually all prescription drugs.Up to this point, marketers and their agencies had relied on the so-
called “O
ne-
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 takesunambiguous 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 promotionalmaterial.
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RELEVANT FACTS
FDA has repeatedly stated over the last decade that it believes the regulatory principles developed for advertising inprint and broadcast media are adequate for, and applicable to, the regulation of pharma-sponsored Internetcommunications. 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 thatare material in light of the representations made by the materials or with respect to theconsequences that may result from the use of the drug as recommended or suggested by the
materials.”
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