Last week I wrote about the online Sleep drug ad wars (see "AmbienCR and Lunesta Duke It Out on Web").
Today I focus on the ads themselves, and especially the "Adwords" sponsored by Lunesta and Rozerem and served up by Google. Specifically, I focus on how Lunesta is in violation of FDA regulations regarding DTC advertising and how Google Adwords allow this to happen.
Here's an example of such an ad:
This is a screen capture I made on November 2, 2006. As I also pointed out last week, you can do a Google search on "sleep medication" and find these ads at the top of the screen in the "Sponsored Links" area.
There's no doubt that the drug companies pay for these ads.
Lunesta Adword is "bAdword"
Can you see how the Lunesta ad is "violative," which is FDA jargon for breaking the law?
I won't keep you in suspense any longer. Notice that the ad mentions both the brand name (Lunesta) and the indication or rather the benefit, which is sleep (as in "Lunesta Sleep Drug"). It also manages to tell you that you can get a full night's sleep with Lunesta.
What the ad doesn't tell you -- and what the FDA requires all drug ads that mention the brand name and the indication or benefits to tell you -- is the major side effects. Or at least provide a direct link to a brief summary of the product labeling as in the Rozerem ad shown on the left. In this ad all you need to do to get the required information is to roll your mouse over the appropriately labeled area. Even so, this ad may also have been violative if it mentioned the indication because mouse rollovers may not be considered "fair balance" by the FDA. The Rozerem ad shown on the left and the Rozerem Adword shown above do not mention sleep, so they are fine as far as the FDA is concerned.
The Rozerem Adword is what's called a "reminder ad." Recent voluntary PhRMA DTC advertising guidelines call for an end to reminder ads on TV, but not in print or on the Internet.
The Lunesta "bAdword" on the other hand is not a reminder ad and the Sepracor folks should receive an FDA cease and desist letter (ie, "warning letter").
Under normal circumstances, that is not likely to happen because (1) the FDA is too busy or too short on manpower to notice and I doubt that they do a systematic review of the Internet to make sure DTC ads served on it are on the up and up; and (2) Adwords served by Google are fleeting; you can see them one minute and then lose them if you reload the page. The FDA can't say, go to www.pharmamarketingblog.com and you will see the violative Adword. It just may not show up!
Complaint Filed With FDA
Realizing that the FDA would never catch this, I reported the violative Lunesta Adword to the appropriate person at DDMAC, the division that oversees DTC advertising. On November 1, 2006 I sent this person an email with attached screen shots as evidence. She sent back an email return receipt and called me to confirm that the FDA would register my complaint and look into this violation.
My conversation with the FDA confirms that these kinds of violations on the Internet are a problem for regulators. It's difficult to keep up with the technology, for one thing. How many ways can ads be served up on the Internet that are virtually impossible to track?
The FDA also does not have any specific guidance for DTC advertising on the Internet and has always said that the same rules apply to the Internet as apply to print and TV.
Personally, I think it's about time for the FDA to stop sweeping Internet drug advertising issues under the rug and come up with some Internet-specific regulations or guidance. For example, is it OK to leave out fair balance in Google Adwords? I don't think so, but Sepracor, who markets Lunesta, can claim that it is hardly possible to include all that information in an Adword, which limits you to 70 characters. I don't buy this as an excuse, by the way. If you can't provide fair balance, then stick to reminder ads or nonbranded advertising like Rozerem does.
This is also about providing a level playing field. If you are a Rozerem ad team person -- and I know a lot of you read this blog -- I suggest that you complain about the Lunesta "bAdwords" program to the FDA. After all, you are playing by the rules, why shouldn't Lunesta?
Industry Self-Regulation Also Needed
Regulations and guidance from the FDA is always the court of last resort as far as the pharmaceutical industry is concerned. Therefore, I suggest that PhRMA get off its butt and issue guidelines for DTC advertising on the Internet as it suggested it would do back when it came out with its TV and print DTC guidelines.
That's my opinion and I'm sticking to it!
Word to Google: If you want to serve pharmaceutical sponsored ads, maybe you can help keep the playing field level and be sure to review each ad that mentions a brand name drug to ensure that it's not violative of FDA regulations. Why not have a "DTC Ad Checker?" You already have some guidelines about serving DTC ads only to US Web sites. That means you attempt to obey EU and other non-US laws. Why not ensure that US law is also upheld? Maybe FDA should give you guys a call about that.
I know you are smart enough to do this. So no excuses, OK?