FDA’s Non-Guidance on Relating Risk Information is FDA’s Loss – Industry’s Opportunity

This week, the FDA issued a Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion.  It is more accurately referred to as a Non-Guidance.  According to FDA's DDMAC, the Internet has not really taken hold yet.  The word "Internet" appears only a single time in the entire 27-page document, making the document largely irrelevant.  Apparently, rather than provide guidance on how the Internet is used by companies to convey information to the public, DDMAC would rather issue policy by Warning and Untitled Letter, playing an endless and non-informative game of Whack-a-Mole.  

The medium that patients probably turn to more than any other to get healthcare information is the Internet.  It is not TV, it is not printed materials.  It is not a booth at a medical meeting.  It is the Internet.  So why would an agency that is trusted with regulating communications between pharmaceutical manufacturers would deliver a Guidance document that covers print materials and broadcasting and intentionally leave out the Internet?  

Apparently those who are guiding DDMAC policy are woefully unfamiliar with the Internet and how it is used by patients.   Instead, they are stating, rather incredulously, that "[u]nless otherwise specified in this draft guidance, the principles set forth below apply to all promotional pieces, regardless of the medium used, or the target audience."  It is a ludicrous statement, particularly given DDMAC's regulatory action against 14 companies using search engine ads.  And, for an agency driven by data, there is no data whatsoever to support the position that consumers and patients use the Internet to learn and absorb information about drugs the same way they do on television or reading a brochure.  You see, there is this thing called "links" on the Internet that allow people to explore and get further information.  People do not act upon a banner ad, it is not a commercial running during the evening news.  People on the Internet are there to learn and act upon the information they learn.  A search engine ad is, in fact, far different from a magazine ad.  The two are not comparable.  The inability to realize that betrays a primitive understanding at best of how the Internet works.

In addition, the FDA wants to rely on a "reasonable man standard" to decide important matters.  But does the evidence indicate that DDMAC can be trusted to be reasonable?  

But the gift from FDA is this.  There are 90 days to file commentary.  Obviously the FDA needs a LOT of commentary on this.  Arnie Friede at McDermott Will & Emery has been spearheading a coalition going that would respond to DDMAC's inability to grasp the Internet principles and provide a pathway to a rational guidance that would inform companies how to operate the many nuances offered by the Internet, such as whether or not a company can or cannot correct information on a Medpedia or Wikipedia page about their drug, among others. (By the way, the words Medpedia, Wikipedia or Wiki also do not appear in the text of the "Draft Guidance" but when I recorded my podcast about DDMAC's outlook on new media, they would not discuss Wikis.  So companies are left to guess, one supposes, what they might eventually decide and risk to be whacked, like a mole.)

Clearly, DDMAC is in over it's head when it comes to formulating policy about emerging media and the conveyance of risk information and marketing.  The 90 day window and the effort underway by Arnie Friede both offer opportunities to industry to speak now, or live under a realm of non-guidance from DDMAC and a long game of Whack-a-Mole.  
Note – After initial publication, this posting was revised to correct a hanging sentence and a typo.  I was in a hurry!

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