Influence. What does influence mean? And what the hell does it mean in regard to the new draft guidance from the FDA?
According to the original request for comment from the FDA/CDER/OCPDP/WTFBBQ, it was actually asked a little something like this:
1. For what online communications are manufacturers, packers, or distributors accountable?
So, when I think of the term influence, I automatically move into what I (If I were a multi-billion dollar pharma company), would be accountable for. As a layperson, and armchair regulatory compliance officer, I think about what the FDA generally determines I'm accountable for:
- My corporate pages
- My brand pages
- My unbranded pages
- My dead-tree publications in medical journals
- My Key Opinion Leaders
- My Patient Advocates
- My promotional materials
- My internal employees
- My customer-facing employees
- Television/Radio/Print ads I pay for
Over the years, it's my understanding, the rules for meat-space have bled over to digital space. Thus, if I buy an ad to be placed on a website, I need to make sure that it's as compliant as a journal ad... it's got to include ISI, make no unapproved claims, use brand and generic name, claims should be the same font size as risk information... all the good stuff.
When I first started doing corporate social media - as an unpaid hobby which almost got me fired because nobody asked me to do it - I was aware enough of the promotional guidance that I didn't put anybody at risk... phew... I was also aware that I had a lot of other rules to play by, most of which summed up as:
- Don't do anything illegal
- Don't be a schmuck
- Be transparent
I wish all guidance could be that simple.
Where was I... Influence... right...
So, like internal corporate social media guidance, influence still seems to be following the same old rules:
- If I've got a relationship with you in which I transmit information to you, and we have a tacit agreement that you will be doing something with this information, then I've got influence over you.
- If you call my 1-800-MY-PRODUCT number, and ask for patient information, which I send to you, and then you blog about it... I've not exerted direct influence over you, and should not be held responsible.
- If I pay you as a KOL/eKOL/COL, and you are writing/presenting on my behalf, that's me exerting influence over you.
- If I sponsor a page on your website, that's me exerting influence.
- If I run an ad on your page, I'm not exerting influence on you, because I'm just asking you to run an ad for me (this assumes I've done some reasonable due diligence about the veracity of your site... standard due diligence... which is why I probably use an ad network and don't negotiate directly with your site).
- If I provide shareable content in a digital space, then that content had better be compliant as an entire capsule; it had better include ISI, links, all the approvable language, and probably even a message that the brand does not endorse/control any of the content that is on the page (shameless plug for my employer's Content Capsule which is designed to deal with that issue...).
In short too late it's more of the same in a different wrapper.
And that's what I get from the first reading of the new draft guidance. I know what influence and accountable mean because they mean the same they did before.
What do I think will be some of the points with which actual regulators will wrestle? I think that many of them will broaden the definition of influence to continue to restrict outreach to patient bloggers. Exerting influence will be read as "over the entire blog" and "over comments resulting from content posted". The most restrictive will even identify influence as "a patient receiving coverage from our patient assistance program" because technically, if you're providing coverage which can be quantified as exerting a financial influence, isn't it safe to assume that you are exerting influence over any content they produce related to your product?!
When I was young - by social media standards, so 7 years ago - I hoped that Pharma would soon be free to do the right thing, the helpful thing, the good thing for patients in the digital media space. Pharma would be able to facilitate patients coming together to share experiences, hope for living with their illnesses. Physicians would be able to share their best practices with each other. Researchers could share open source data, and products that weren't financially viable would gain new life in new markets. No longer would Pharma be 3 years behind the technology curve. Everybody would win, and Pharma would move out from under the umbrella of distrust.
Now that I'm older, I marvel at my youthful naivete and wonder why I didn't add, "and unicorns will dance in the streets handing out chocolate bars and money to the poor...". Okay, it's not actually that bad.
What I have learned is that regulation exists for a good reason even if the FDA gets to play by different rules *cough cough* and that the wheels of progress move, albeit slowly. The FDA's new draft guidance does not IMHO break any new ground. It's telling us the ground we were on was the right ground. It's codifying the way we've been playing for the last, almost 5 years already. What I hope it's not doing is freaking out regulators... more than they're already freaked out...
TRANSPARENCY STATEMENT: I work for tWist Marketing and have a vested interest in people trusting my opinion for the purpose of making a living in the digital marketing arena. The opinions expressed here represent my own and not those of my employer... yell at me, not them... although, I'm sure if I've pissed them off, I'll hear from them anyway :)
