14 Warning Letters in a Day! What's That About?

Last week, FDA's DDMAC issued  a whopping 14 Untitled Letters in a single day.  It is a good thing they did not do it on April 1 - no one would have believed it.  That number of letters, issued in a day (April 2) outpaces most quarterly volume of Untitled and Warning Letters for the past 8 years. 

 Moreover, they were all issued about a single topic - online advertisements.  Each of the advertisements were sponsored links that appeared on search engine results pages.  A sponsored link is a short ad with a web link to a product.  What does the issuance of an entitled letter by DDMAC based on sponsored link ads mean for pharma and the use of the Internet for marketing?  

From the FDA's perspective - it actually doesn't mean much.  As written here often - it is the message, not the medium.  

The regulatory action against the fourteen companies would have occurred had they been involved in any other medium.  The letters were not issued because of the use of online media, they were issued because the type of intervention chosen by the companies was not within regulatory confines.  Ads for drugs were run without any risk information.  Period.  

But there is, however, justifiable reason for the companies involved to have been unaware of the fact that their actions tripped a regulatory wire.  Confused?  Let's try to clarify.

Regulatory guidelines do not allow for an ad to be displayed, whether on television, radio, in a magazine or a brochure, without accompanying risk information.  The Internet would not be any different.  An ad that advertises a drug without risk information is in violation and trips the regulatory action wire.  In short, it would not be the medium, it would be the message.

There is an exception to the need to display risk information in an advertisement when the ad is in the form of a "reminder ad".   A reminder ad provides the consumer with the name of a drug, but does not have the indication for which it is used nor does it make any claim about efficacy.  It is assumed that the consumer will know what the drug is for.   Also, reminder ads are not permitted for drugs that carry black box warnings on the label, which of course, is an increasing number of drugs.  

The ads that were the subject of the 14 Untitled Letters were ads.  However, these ads were not classifiable as reminder ads, because they included not only the name, but also a rough indication of what the drug is for, and a link to the web site.  In addition, several of the drugs being advertised carried Black Box Warnings which would disqualify them from reminder ad status.

So why did the companies run these ads if they weren't reminder ads and not include risk information?  It is because of the so-called "one click rule" which means that if risk information is only one click away from the promotion of a drug online, that is is within the regulatory graces.  Unfortunately for the companies, the "one click rule" is not a rule at all, rather it seemed to a strong perception among marketers, and one that was not, it turns out, correct.  In fact, for some time, it has been speculated that reminder ads would be a violation of regulatory rules and could likely trip a Warning Letter.  

All of this begs the question - why doesn't the FDA develop a guidance around new media?  From their perspective, it is clear that they don't think they have to do that.  They do feel that the regulations as written, cover the situation.  And technically, they are correct.  

But clearly there are perceptions about social media that leave many questions on the part of marketers.  And in addition, there exists a great deal of nuance in the digital realm that could use clarification.  For that reason, if no other, the FDA should be exerting some leadership and vision, particularly as the environment is changing so rapidly and as written here on March 19, it is imperative that the FDA undertake an effort to clarify its positioning further for industry.  

The podcast with FDA's DDMAC posted on March 17 by Eye on FDA was a start.  At the time, however, I wrote that " understanding the complete FDA point of view about Web 2.0 and pharmaceutical companies is going to be a process, not an event.  A comprehensive set of answers to the many outstanding questions cannot be gotten in one sitting."

However, perhaps now more than ever, as we hurdle towards Web 3.0, it is essential that the agency return to its era as a leader and now a follower.  Dr. Hamburg would be well informed to take note.  Communications has changed drastically and continues to evolve.  The FDA must evolve with it and recognize its responsibility.  To date, it has not.

In many companies, after all, the regulatory culture can be so strict that the reception of an Untitled or Warning Letter can be so strict, that the person responsible can lose a job.  These Untitled Letters carry a great deal of responsibility and the FDA should recognize as much.    It is past time for the agency, which does not wish to be perceived as acting in a "whack the mole" mode - defining the environment by its regulatory action rather than by guidance.  But Friday's actions demonstrate that the agency is, in fact, whacking pharmaceutical companies when they go out of line in new media. This is in spite of the fact that they have not addressed new media.  They have done no work to develop either the agency's thinking nor its process for addressing the nuance of online marketing rather than engaging in the extreme sort if drama of sending 14 letters to the industry.  The issuance of 14 Untitled Letters, after all, is just as much of an indictment of the industry as it is the agency that regulates them.  Simply, that is not a sound way to develop or enunciate policy.   FDA, as we enter Web 3.0 when all of these communications systems begin to integrate, it is time for you to catch up to Web 2.0.  In this respect, the FDA has failed not only consumers, but the industry it regulates, otherwise 14 Untitled Letters would be completely unnecessary.   

Comments

[John Mack]

Mark,

I do not understand how "The Internet would not be any different," yet some pharma companies THINK it's different and have evoked the so-called "one-click" rule - which can ONLY apply to the Internet - for many years?

Could it be possible that ad agencies, including Google, I might add, encouraged or duped their pharma clients into running these ads? I discuss this in more detail on Pharma Marketing Bog: http://tinyurl.com/cm2byy

[Eileen O'Brien]

Mark,

What's interesting is the FDA letter to Sanofi about Plavix. It actually talks about "sponsored links" but references natural search engine results NOT paid search ads. Could it be a mistake since these are not sponsored ads and these results cannot be bought?

[Charles Willson - ePharma]

If the guidance requires removing reference to the brand name in the ad copy, I wonder what the FDA position is on the brand name being part of the displayed link URL? More questions that answers at this point.

[Mark Senak]

Agreed which is just another reason that these letters are a poor way at establishing policy. They say what you can't do, they don't say what you can do. Badly played by DDMAC.

[Daniel Ghinn]

Mark, thanks for raising this and for keeping your finger on the pulse of what the FDA is up to.

IMHO the FDA action does answer lots of questions about where the boundaries are. Of course there are - and probably always will be - questions unanswered as digital media continues to open up new ways of engaging patients & stakeholders, and pharma legal & comms teams attempt to tread an acceptable path.

[Daniel Ghinn]

@ Charles Wilson - ePharma: One of the warnings concerned a brand mentioned only in the URL, not in the ad text or headline. I assume that the issue here is that the FDA sees the URL as part of the ad itself.
More analysis at http://creationinteractive.com/articles/fda-warns-pharmaceuticals-about-google-advertising/