Jack Friday (aka "Insider") over at PharmaGossip blog asks if the Zyrtec print reminder ad shown on the left is legal (see "DTC -- Is It Legal?"). This consumer print ad was found in the April 21, 2008 issue of TIME Magazine.Sure it's legal! Why not?
Jack is probably thinking that it violates Principle #10 of PhRMA's Guiding Principles for Direct To Consumer Advertising for Prescription Medicines that calls for the elimination of so-called "Reminder Ads," which are usually 30-second TV commercials that mention a drug's name without stating the health conditions for which the medicine is approved and without listing the major risks associated with the drug.
Here's why this Zyrtec print ad is not illegal: Reminder prescription drug ads are perfectly legal from a regulatory point of view, PhRMA's DTC Guideline #10 only applies to TV ads and NOT to print or Internet ads (or ads posted on telephone poles), PhRMA's DTC guidelines are not legally binding, and Most importantly, Zyrtec is NOT an Rx product -- it is OTC and can be sold without a prescription!
Why would the Zyrtec marketers resort to a reminder print ad for their OTC product when they are not required to list all the major side effects as would be required in an prescription non-reminder drug ad? In my review of Rx and OTC print ads (see "Print DTC: How Does It Measure Up?"), ordinary OTC print ads are notoriously lacking side effect information.
Obviously, the Zyrtec marketers want you to call 1-800-4-ZYRTEC, which I did.
I wonder how many people like me actually called the 1-800 number? I was hoping for a live person to answer so I could claim to have found the missing Claritin! Unfortunately, all I got was a recorded audio ad that directed me to the Web site, which directed me to sites where I could buy Zyrtec online! You can hear the recording by clicking here.
Considering that Americans -- especially gun-totting, religious, small town Americans -- are not that fond of reading, this is a good ploy. Of course, they could have just put the Zyrtec Web site URL in the ad and eliminated a step. That would have been a good strategy if we all had iPhones with built-in Internet access.
P.S. A post on Adrants suggests that this print ad follows on to a guerilla marketing tactic that actually posted flyers on phone poles in Boston! I doubt this is a true story -- more likely a Web 2.0 plant by crafty Zyrtec marketers.
Why would you claim to have found the missing Claritin? Claritin wasn't missing, your time was... that's the whole point of the ad.
ReplyDeleteOK, I stand corrected. I would now say -- "Hey Zyrtec! Claritin called. They're looking for your lost benefit statement!"
ReplyDeleteOh wait! 2 hours lost waiting for Claritin to work -- that IS the benefit statement!
ReplyDeleteDuh!
I hope small-town Americans aren't as dumb as me!
John:
ReplyDeleteZyrtec flyers ARE being posted throughout different cities. See my blog post here for more information.
Fard
What is illegal is the posting of anything to a telephone pole or other structure.
ReplyDeleteRight! See my follow-up post: Zyrtec Telephone Pole Ad Campaign: Guerilla or Gorilla Marketing? http://pharmamkting.blogspot.com/2008/04/zyrtec-telephone-pole-ad-campaign.html
ReplyDeleteJohn - PhRMA guidelines have nothing to do with whether this is legal or not.
ReplyDeleteThe FDA regs (which, unlike the PhRMA Guidelines, are definitely not voluntary) define a reminder ad as one that contains the brand name and no "representations" (i.e., claims) about the product or which mention the indication but not the brand.
So let's see: this ad contains (1) the brand name, as part of the phone number; and (2) a representation about the product (works faster than Claritin).
Thus it's not a reminder ad. It's a "full product ad" which requires (1) a "major statement" of risks, including major adverse events, warnings, and contraindications; and (2) inclusion of the "brief summary" (which is brief only in comparison to the full prescribing information, or PI).
Or at least it would if Zyrtec were a prescription drug. What lets it off the hook is that it's an OTC drug, whose advertising is not held to the same standards of disclosure. (OTC advertising, in fact, is not even regulated by FDA but by the FTC.)
Were this an Rx drug, however, arguing that the claim is only implied would cut zero ice.
FDA claims full authority to treat implied claims as if they were made explicitly -- as they did in the now-notorious "Wild Thing" TV spots, where it found that the line, "Remember the guy who wanted to spend his whole honeymoon in bed? He's back." constituted a claim for Viagra (which anyone not raised in a monastery knew all along).
Two final thoughts about this "guerilla" campaign.
(1) Do you suppose anyone noticed that the same three tabs were "torn" (actually die-cut) off every "hand lettered" flyer,leaving exactly the same "tears"? (2) How many people who post these kind of flyers would take the trouble to conscientiously "hand-letter" the neat little "circle R" after "Claritin" on each and every one?
Bruce,
ReplyDeleteThanks for the notes about PhRMA guidelines and FDA regs.
Good catch re: registered trademark symbol
Also, who but a pharma ad copy writer and legal/regulatory reviewer would also use all CAPS for a drug brand name???