Sanofi-Aventis' Ambien CR ads skirt new DTC rules

Medical Marketing and Media, Dec 2005 by Iskowitz, Marc

WITH JUST MONTHS of patent life left on its original Ambien, Sanofi-Aventis kicked off DTC for Ambien CR (zolpidem tartrate) last month with a 15secondTV reminder ad, a 60-second spot and a coupon for a free seven-day trial.

Those tactics drew grumbles from some in the industry, because they run counter to PhRMA's Guiding Principles for DTC ads, which-while not in effect until Jan.l-have inspired some other pharma firms to adopt a more educational tone in advance.

"We are compliant with the rules as they are in place right now, and we will be compliant with the revised PhRMA guidelines moving forward," SanofiAventis spokesperson Melissa Feltmann told MM&M.

Back in August, the firm said it is "strongly committed" to following PhRMA's guidelines. At the time, Timothy Rothwell, president and chief executive of Sanofi-Aventis U.S., said, "Overall, DTC advertising has been beneficial to both patients and physicians. Can we do it better? Yes. And that's what the guidelines are all about."

Yet several facets of the Ambien CR campaign skirt the spirit, if not the letter, of the PhRMA principles. The campaign employs a 15-second TV reminder ad of the sort banned under the DTC guidelines.

A voiceover in the 60-second spot presents risk and safety information as actors portray a family hurrying through its morning routine in the background. The principles, meanwhile, urge "clear, understandable language, without distraction from the content," and much of the ire over DTC ads has focused on busy visuals distracting from risk information.

The coupon offers a seven-day free trial of Ambien CR in a mixture of print media but contains no fair balance.

Ambien CR gained approval in September. Sanofi-Aventis launched the drug to doctors in October and to consumers a month later. PhRMA recommends delaying DTC ads to give health professionals an "appropriate amount of time" to learn about a new medicine.

"The new guidelines go into effect on January 1," said Ken Johnson, PhRMA SVP, communications, "and we expect at that time that all of the signatories will fully comply with the code."

Pfizer and J&J have already adopted a more educational approach featuring explicit information on the balance of risks and benefits. -Marc Iskowitz