The white elephant in the room: the FDA hearing and DTC

The FDA hearing on social media took place almost a month ago already and a lof of ink (or pixel for that matter) has flown since on what was presented. I vividly encourage you to dig through the sources on Fabio Gratton’s excellent #fdasm site to paint your own picture of the content.

In my simplitic view, however, I would classify the presentations on proposed guidance at the hearing into three categories:

1. Enable direct to consumer advertising (DTC) via social media- by allowing links to fair balance and safety information (”one-click rule”)

2. Improve patient safety - via social media AE reporting (MedWatch icons) and correction of gross misinformation

3. Enable collaborative content creation- define a transparency framework for content created in collaboration with patients online (3 Cs proposal)

Yet, after having gone through most of the great content from the hearing as well as through reactions afterwards, I much regretted the little amount of e-patient input. Only 9% of the speakers at the hearing (accoring to John Mack’s great analysis) were consumer advocates.

Why was this? Did patients not care about improving access to better information and enabling informed health choices? Did they not want to help define pharma’s role in their choices?

I came across this discussion initiated by Lisa Emrich, one of my favorite MS bloggers and an incredibly sharp thinker. Lisa popped the question on FDA, social media and pharma to her MS community on health central. She gathered no less than 43 comments within hours! A lively discussion on the value of DTC, to say the least. This is one of the rare patient discussions I witnessed about the hearing, so I invite all of you to read it with great intrerest. I also decided to analyze it in greater detail for you. Below you thus see a tag cloud attempting to capture  this insightful discussion. As you can see, it was driven by a debate on information vs. advertisement and the pharmaceutical companies’s role in providing it:

Patients are saying they need good drug information to make informed health choices - not more mechanisms to enable pharma drug advertisement. Unfortunately, they perceived the FDA hearing to be mainly about applying DTC regulations to the context of social media.  Maybe, this was the reason for the absence of most prominent e-patients? Maybe, there was a big white elephant in the room during that hearing- called DTC advertisement?

Patients have been turned off by years of abusive DTC TV ads and despise the idea of it leaking into their social media haven. And I have to agree: Social media is not compatible with DTC! In my opinion, DTC  is not the right framework to define and regulate patient/pharma interactions in social media. There are three reason’s why I believe this:

1. Social media is Global, DTC is local!

Social media information travels across national borders. Its most definite limit is language, not geography, though patients frequently translate US information to make it accessible in languages were information is scarce. DTC is banned in most countries around the world, except US, Canada and New Zealand - so how is any DTC guidance ever going to be applicable to social media? How can you create guidance that is adapted to the global nature of social media?

2. Social media marketing is pull, DTC is push!

This post by ClikZ took the words right out of my mouth:

Social marketing isn’t about pushing ads at target consumers, even if you know where to find them. It’s about listening to what they’re saying.

Social marketing isn’t about shouting a made-up claim that your product is great. It’s about respectfully asking their opinion and observing how they tell their friends and peers about why they love or hate your product.

Social marketing isn’t about getting your message to a ton of people (reach). In fact, it’s better if only those people who wanted the information could find it, when they wanted it.

Social marketing isn’t about how often you beat people with your ads (frequency). It’s about allowing them to find your information in the words they choose to use when they search.

3. Social media believes in empowering patients, DTC does not!

Donna R. Cryer from DC patient summed this up brilliantly: I’m not as afraid of health social media because I believe in the intelligence, passion, persistence and generosity of my fellow patients (and I still believe in doctors). FDA has a strong role in ensuring that information by regulated entities (under their control or influence) is accurate and meaningful …  Pharmaceutical companies and other regulated entities should listen more than talk and only interact to provide value to patients, as defined by patients.

I believe patient involvement around the hearing was quiet low, because the questions asked did not resonate with patient advocates. Patients do not want to figure out how to apply DTC to social media. Yet, I also believe that this is throwing out the baby with the bath water. The FDA hearing was a much needed catalyst to get important changes going in redefining the pharma/patient relationship and more importantly in building new bridges for patient empowerment. It was the first time the FDA acknowledged that patient generated content on social media was special and needed its own set of regulations.

I thus would like to encourage patients to speak up and participate in the commentary that the FDA is gathering until February (Please also click here to participate in John Mack’s survey on the matter).

Please seize this important opportunity to define the relationship you would like to have with pharma: if you do not want DTC applied to social media speak up! Don’t let an elephant cheat you out of an important opportunity to get heard!

If you do not care about DTC, think about improving AE reporting and enabling collaborative content creation. In my eyes, these will be the real advances in terms of social media guidance, because they will allow you to get access to better information and to make safer health choices.