100 East Penn Square|Philadelphia, PA 19107© 2009 Digitas Health phone (215) 545-4444 |fax (215) 545-4440 |digitashealth.com
Organic Search Compliance POV
Analysts: Larry Gurreri, VP/D Media
June 2, 2009
Bruce Grant, SVP Strategy & Analysis
EXECUTIVE SUMMARY
FDA’s recent mass enforcement action
targeting paid search links left several key questions unansweredregarding other marketer-controlled search tactics, such as for directory listings and sponsored text links, aswell as for the metadata included in web page code that influences organic search results.Digitas Health believes that directory listings and sponsored text links should be regarded as subject to thesame requirements as paid search links and be constructed either in reminder form, using the drug namebut no other claims or representations about the drug, or in help
—
seeking form, referencing the treatedcondition but making no mention of the drug.Because marketers do not control the way in which search engines construct organic search listings, DigitasHealth believes that metadata and browser title-bar text which accurately reflect page content, remainwithin label, and do contain overt marketing language carry little if any risk of regulatory exposure.
BACKGROUND
On April 2, 2009,
FDA’ s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued
lettersto 14 leading pharmaceutical companies, citing 48 separate brands for paid search listings with a range of violations, including inadequate communication of indication, failure to use the generic name, and, mostcrucially, omission of risk information in the body of the listing.This last charge came as a surprise to many, who up to this point had relied on the so-called
“
one-clickr
ule,”
which posited that presentation of the
major risks (also known as “Important Safety Information” or
ISI) on the linked page constituted adequate risk disclosure. The language of the letters, however, makes itclear that FDA rejects this theory
—
“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.
”
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While the letters clarified FDA’s expectations with regard to paid search listings, lingering concerns and
uncertainty persist among pharmaceutical marketers with regard to
organic
(non-paid) search listings,
directory
listings, and
text-link
sponsorships, which share several key attributes with paid search listings.
RELEVANT FACTS
The FDA has repeatedly stated that it believes the regulatory principles developed for print and broadcastadvertising are adequate for, and applicable to, pharma-sponsored Internet communications. Indeed, it hasrepeatedly 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 aremisleading if they fail to reveal facts that are material in light of the representationsmade 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.”
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