Last night, while watching 60 Minutes on CBS, there was an “NFL Today” playoff update break with James Brown.
As the spot came on, Brown first mentioned that the break was sponsored by CHANTIX, Pfizer’s smoking cessation pill and program (see “A Pill, a Plan, a Profit? — Chantix!“). He did NOT mention its indication, however. The CHANTIX logo was right next to him, very visible, fairly large, and near the center of the screen (see my representation at left).
After about 30 seconds of playoff scores came the ad, which was a “non-branded” Pfizer ad for the “My Time to Quit” web site (http://www.mytimetoquit.com).
My question is this: is the sequence [brand sponsorship message — 30 seconds of show — non-branded ad associated with the previously mentioned brand] a “Bookend Ad“?
FDA has issued guidance saying such ads violate their direct-to-consumer (DTC) ad regulations (see “Guidance for Industry: ‘Help-Seeking’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms.”
To answer my question, you first have to determine if the first sponsorship message is a “Reminder Ad” and if the second is a “Help-Seeking Ad,” which are two types of ads defined by the FDA in its guidance.
In a Reminder Ad, a product name is mentioned but NOT the indication. According to the FDA, reminder ads are exempt from the requirements for adequate directions for use and adequate warnings (see more on this here).
A Help-Seeking Ad, on the other hand, discusses a particular disease or health condition, but does not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device (see here).
Neither a Reminder Ad nor a Help-Seeking Ad is subject to the requirements for the disclosure of risk information and other requirements under the Federal Food, Drug, and Cosmetic Act. But, as I mentioned above, when used in combination — even with a short interval between them — these ads would raise red flags at the FDA.
Letter vs. Spirit of the Law
Pfizer and many other drug companies have said that they will no longer run reminder ads on TV. I believe it is commonly-accepted among pharma advertising experts that sponsorship mentions of product names that include a prominent image of the brand name/logo are not technically reminder ads.
Also, an ad that encourages viewers to visit a Web site like www.mytimetoquit.com rather than a doctor for help in dealing with a specific medical condition may not technically be a Help-Seeking Ad.
Technically, therefore, Pfizer probably has not violated the letter of FDA law nor PhRMA Guidelines on DTC advertising. But did Pfizer violate the spirit of these laws and guidelines? Does it matter whether or not drug companies are spiritually aligned with these laws and guidelines?
What do you think?
