Ads Linking “Help-Seeking” and Full Product Spots Helps Consumers – Pfizer

Similarities between branded ads and disease awareness ads may benefit consumers and should not be prohibited by FDA, Pfizer says.

"There are good reasons to believe that some perceptual linkages actually serve to focus consumer attention on the important health information that disease awareness communications convey," Pfizer's comments on FDA's disease awareness ad draft guidance states.

"It is considerably more difficult to develop successful consumer-directed promotional communications than many people realize" because of the need to "break through ubiquitous 'commercial chatter' to reach the people who can make good use of the information provided."

Therefore, "when a certain advertising campaign connects with the public - establishing both recognition and trust among consumers - it makes sense from a communications standpoint to extend the usefulness of the symbols and spokespersons by employing them in the service of 'help-seeking' messages."

One example of a beneficial linkage, Pfizer suggests, could be the use of a celebrity spokesperson in both types of ads. The combination of the two ads visually linked by the spokesperson could "further encourage consumers to act on the information provided."

FDA published a draft guidance in February that encouraged use of disease awareness ads (¹ (Also see "Disease Awareness Ad Guidance Stresses Need For “Distinct” Messages" - Pink Sheet, 9 Feb, 2004.), p. 6). The guidance cautioned that messages that were perceptually similar and/or physically or temporally related to product advertisements could result in the product being deemed misbranded.

The original comment period ended in May but FDA extended the comment period to Aug. 10 (² 'The Pink Sheet' May 31, 2004, In Brief). Pfizer submitted its comments Aug. 6.

Pfizer said it does not seek to limit FDA's ability to challenge cases of "classic bookending," where sponsors run a help-seeking ad and a reminder ad in close temporal proximity. "A close nexus between two such ads in time or space could well justify the conclusion that the help-seeking ad was conveying a brand message," the comments state.

Pfizer acknowledges that linkage between reminder ads and help-seeking ads could be problematic because neither ad "brings risk disclosure or other mandated information into the mix."

However, if a help-seeking ad were conceptually or temporally linked to a full product ad, the required risk disclosures of the latter "would be necessarily brought into the combination," the comments state.

"Thus, there would seem to be no basis for concern about possible evasion of full product risk disclosure rules in this situation or any resulting misleading of the recipients of the linked messages."

Pfizer suggested that FDA evaluate the effect on consumers of conceptually linked messages before finalizing its guidance.

"FDA should begin by considering evidence as to whether linked messages offer benefits or pose harms to the public health," the comments state. "Pfizer urges FDA to undertake these necessary steps before the agency either enforces the new guidance in individual cases or finalizes it."

Pfizer is working with consumer and medical groups, including the National Consumers League and the National Medical Association, to develop evidence on how consumers respond to ads that are conceptually linked. The company plans to submit that data to FDA.

Pfizer is also asking FDA to clarify how different and how distant help-seeking ads must be from direct-to-consumer full product ads to comply with the agency's disease awareness draft guidance.

"The guidance offers no clear boundaries to guide manufacturers who may wish to continue funding help-seeking ads when linkage could be asserted," Pfizer's comments state.

The guidance therefore could be interpreted as "imposing a de facto ban on the use of any similar visual or aural elements in help-seeking messages and product advertising," the comments add.

With respect to perceptual similarities, Pfizer is seeking input on "what precisely crosses the line." The comments ask, "Would common coloration be enough? A common typeface for text? What if it were one or the other but not both?"

When considering physical or temporal proximity, Pfizer seeks clarification about "how close is too close."

"In print, would the appearance of a help-seeking message and a product ad in the same publication be too close? What if the publication was one edition of the newspaper but the two communications appeared in different topical sections, e.g., sports and the feature section? If the publication were a magazine, would it matter if the issue had 30 pages or 300?"

"If the medium were television, would it matter whether the two communications aired during the same program but during different commercial breaks?"

"Would it matter if the two communications aired during different episodes of the same program - and would there be a distinction drawn between program episodes that air once a week versus those that are 'stripped' across the same time period every weekday?"

Pfizer asserted that "the lack of clear directives for manufacturers appears to stem from the lack of factual evidence that might help determine the extent to which consumers actually do link help-seeking and branded messages."

Without further clarity from FDA, the guidance may "inadvertently diminish manufacturers' incentives" to support disease awareness ads, the comments state.

"If help-seeking ads can remain outside product disclosure requirements only if they are stripped of all 'perceptually similar' stylistic elements that would potentially identify a relevant drug treatment...some manufacturers might opt instead to shift resources to product ads where the regulatory requirements are clear," the comments state.

In response to FDA concern about potential linkage between a Novartis help-seeking ad and promotions for its antihypertensives Diovan and Lotrel , Novartis cautioned that excessive intervention by the agency may deter the company from supporting unbranded messages (³ (Also see "Novartis Unbranded Hypertension Ad Cited For Link To Diovan Promotion" - Pink Sheet, 26 Jul, 2004.), p. 32).

Pfizer also objects to the suggestion in FDA's guidance that single-product companies or firms that market the only product in a therapeutic category should be wary of supporting disease awareness communications.

FDA's draft guidance notes that while such companies are "not automatically disqualified" from sponsoring help-seeking ads, their ads will be carefully scrutinized by the agency.

The Biotech Industry Organization asserted that such language is unfair to small biotech firms (⁴ (Also see "FDA Disease Awareness Ad Policy Is Unfair To Small Firms, BIO Says" - Pink Sheet, 7 Jun, 2004.), p. 16).

Pfizer interpreted that section of the guidance to mean that "FDA may determine a pre-formed linkage - based on its own perception and without regard to whether the audience knows whether a manufacturer sells only one product or offers the lone product approved for a particular condition."

Therefore, "as a practical matter, it seems that a single-product or category-exclusive company would have to eliminate references to the firm's name from the message" in order to comply with FDA's policy.

Pfizer suggested that a restriction on the usage of manufacturer names and logos in help-seeking ads could be extended to multi-product companies or firms that market products within crowded therapeutic categories that "heavily advertise" any product.

"If any manufacturer heavily advertised a particular product, it is possible that consumers would associate the maker's name with that product, regardless of how many other treatment options existed for the condition or how many other drugs the manufacturer marketed."

"Does this mean that all manufacturers engaged in significant amounts of consumer-oriented advertising should take the precaution of eliminating the last vestige of their business identities - the firm name and logo - from their help-seeking messages?"

Pfizer challenged FDA's ability to regulate unbranded ads in light of First Amendment concerns. "It is not at all clear that help-seeking messages can or should lose their full measure of First Amendment protection simply because the government has linked them with product ads in some conceptual sense."

The Pharmaceutical Research & Manufacturers of America also suggested that FDA may be overstepping its bounds by attempting to regulate ads that do not contain product information (⁵ (Also see "DTC Comments Support FDA’s Goals; PhRMA Watching “Boundaries”" - Pink Sheet, 17 May, 2004.), p. 36).