Ad Offers Ambien CR Samples

NEW YORK Sanofi-Aventis’ first consumer advertising for the long-awaited Ambien CR sleep drug appeared in the Nov. 21 edition of The New Yorker this week, and the effort relies heavily on a seven-day free trial coupon offer.

The print ad runs without any educational, risk, efficacy or side-effect information, and does not state what disease or condition Ambien CR is intended to treat. Side effects of Ambien CR include memory loss and addiction, according to the company’s Web site, and the drug cannot be taken with alcohol.

The marketing code produced by the Pharmaceutical Research and Manufacturers of America—and signed by Sanofi in August—requires print advertising to carry such information. That code, however, only comes into force on Jan. 1, 2006, according to PhRMA.

Sanofi’s ad indicates that it intends to take advantage of the walk-up period before it fully complies with the new code.

Melissa Feltmann, a Sanofi representative, said the ad complied with Food and Drug Administration rules, which do not require risk information if the ad does not state what the drug is used for or how it works.

“We don’t mention what it’s indicated for, and we don’t make any claims, so we don’t have to provide any fair balance,” she said. “Fair balance” is the industry phrase describing the lengthy recitation of side effects that accompanies much drug advertising.

Feltmann declined to discuss Sanofi’s marketing strategy, but said the company would comply with PhRMA rules in 2006.

Sanofi’s ad agency, New York-based Publicis, did not immediately return calls for comment.

Sanofi spent $65 million on Ambien advertising last year, per Nielsen Monitor-Plus.

The all-text ad states in bold type: “Free Ambien CR.” Under that are tear-off tabs of the sort found on neighborhood handbills stuck to lampposts by people advertising rooms for rent. “Ambien CR 7-day free trial,” the tabs say. A tear-out coupon is also attached for consumers to bring to their doctors.

If the ads look like they were produced for a going-out-of-business sale, that’s because, in part, they were.

Sanofi loses its patent protection on the original Ambien in 2006. Ambien CR is a “controlled release” version of its $2 billion bestseller, designed to keep patients asleep all through the night, rather than simply induce sleep at bedtime.

At the same time, new competitors such as Sepracor’s Lunesta and Takeda’s Rozerem have beset Ambien.

But it is the ad’s transgression of the spirit of the PhRMA code, if not the letter, that is most notable. The ad, if it were to continue to be placed after Jan. 1, would arguably violate four of the 15 “guiding principles” agreed to by Sanofi:

No. 3 requires educating customers about the medicine and describing the condition for which a drug is prescribed. There is no language in the ad on those topics.

No. 6 requires companies to spend an “appropriate amount of time” educating physicians about new drugs before urging consumers to descend on their office. Ambien CR was approved on Sept. 6 and only made available for prescription in the first week of October.

No. 9 requires print advertising to include information about preventative care, such as changes in diet and exercise, which may help the condition. The Ambien CR ad contains no such information.

No. 11 requires a “balanced presentation of both the benefits and the risks” of the drug, which is also absent from the ad.

PhRMA’s code is voluntary, but the group has an independent panel that will evaluate ads produced by signatory companies. It is not clear what disciplinary action PhRMA would consider, if any, against a violator company, other than merely identifying errant marketers.

Sanofi gave an upbeat assessment of Ambien’s performance in its third-quarter statement on Nov. 8. In the nine months through September, Sanofi reported sales up 8.8 percent to 948 million euro (about $1.1 billion), and said a 3,500-strong sales force was detailing the product.