Manufacturers may need to reevaluate their use of celebrity endorsers in light of FDA's draft DTC guidances to ensure that disease awareness ads are distinct from product-specific ads.

"One could argue that just having an individual who is a celebrity spokesperson for a company on a particular product...go out and do a disease awareness ad" would be prohibited, Abbott Global Pharmaceutical Regulatory Affairs Director Michael Misocky said during a Pharma Audioconference March 23.

"Even though it follows all the other criteria and doesn't make any particular representation about a product, for example, and is not in temporal proximity...is the perception there because that individual is so well known?"

FDA issued three draft guidances on direct-to-consumer ads in February (¹ Also see "FDA Releases DTC Guidances; “Not The Last Word” On Ads, McClellan Says" - Pink Sheet, 9 February, 2004., p. 3). The Federal Trade Commission will also be considering the use of celebrities in an update of its guidance on product endorsements (² Also see "FTC Updating Product Endorsement Rules; Asks Rx Industry To Comment" - Pink Sheet, 29 September, 2003., p. 35).

FDA's guidance on disease awareness ads aims to make it more difficult for manufacturers to skirt the rules about "reminder" ads by tying educational ads too closely to product-specific ads (³ Also see "Disease Awareness Ad Guidance Stresses Need For “Distinct” Messages" - Pink Sheet, 9 February, 2004., p. 6).

APCO President-Regulatory Services Wayne Pines said companies will need to ensure that disease awareness and reminder ads do not have the same "look and feel."

"I think that what these draft guidances will lead to is a rethinking of the way that advertising has to be designed throughout the life cycle of a product so as not to get locked into a particular look and feel for an ad such that it would prohibit a different kind of advertising from a regulatory standpoint," he said.

"It may very well be that the solution from a company's standpoint and the approach that advertising agencies will recommend is two different physical appearances for disease awareness ads as contrasted with reminder ads."

The guidances will likely affect the structure and oversight of contracts between manufacturers and their ad agencies to ensure appropriate placement of the different types of ads.

"When you are working with the reminder ad and the disease awareness ad together, it is important to structure a contract or communications with your TV network appropriately," Misocky said. Firms also need "to make sure your ads aren't juxtaposed right next to each other in a journal."

Pines said companies also need to establish internal processes to review where advertising is placed.

"That's going to place a new responsibility on regulatory affairs and the lawyers within the companies....There has to be some determination made as to whether they are in compliance with that particular guidance," he said.

The scope of FDA's draft guidances on print DTC advertising could also extend to other promotional and labeling materials, Misocky said.

"I think the scope of these guidances is a little broader than it appears," Misocky said. "It appears there is a little fair balance encroachment with the window of risk information, and it also seems to appear to apply to labeling materials."

The guidances "could apply to unbranded campaigns or disease awareness campaigns out there where a company is combining that with maybe a reminder magnet that would technically not be in the spirit of these guidance documents," he said.

In the brief summary guidance, FDA suggests use of a "risk information window" with bullet points as an alternative to including such information in the body of the ad (⁴ Also see "Risk Information “Window” Proposed By FDA For DTC Print Ads" - Pink Sheet, 9 February, 2004., p. 4).

Misocky's comment followed a question on whether the brief summary guidance can be applied to other drug company materials, such as newsletters and brochures, that are distributed in physicians' offices and pharmacies.

"The philosophy certainly extends to that, although relative to the guidances it is pretty specific" concerning print DTC ads, FDA Associate Commissioner for External Relations Peter Pitts said.

DTC Guidances Could Limit Use Of Celebrity Endorsers Outside Of Product Ads

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