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New White Paper Addresses Regulatory Issues in Social Media for Pharma Marketers
I'm pleased to announce the newest Cymfony Influence 2.0 White Paper: "Connecting with Patients, Overcoming Uncertainty". We've collaborated with other industry experts to help pharmaceutical companies navigate the complexities of launching social media initiatives within the restrictions of DTC promotion regulations.
We're often asked by our pharma clients and prospects how to engage in social media given the strict FDA regulations around direct-to-consumer marketing. The FDA hasn't issued any guidance (in fact, they haven't issued guidance for Internet marketing). For a long time we looked for others who had made suggestions or analyzed the issues involved, to no avail.
So we've put a stake in the ground -- you can download the paper here. I had two great co-authors on this project: John Serio, a lawyer with Seyfarth Shaw LLP who specializes in food and drug law and regulations, and Fard Johnmar of Envision Solutions, a healthcare marketing communications consultant.
In the paper, we propose a framework for identifying the key issues across the entire spectrum of social media types. We review the core principles that are the foundation of DTC promotion regulation and discuss how they should be viewed in light of social media's unique characteristics. We zero in to show how to assess adverse event reporting requirements, off-label promotion risks, and fair balance when designing a social media initiative.
Of course, nothing substitues for detailed FDA guidance. But we believe drug companies can participate in many types of social media without undue risk. We hope this paper will give marketers, regulatory compliance, and legal professionals in healthcare companies a common understanding of the issues, and ideas on how to mitigate the risks and become part of the active conversation that patients are having every day.
My co-authors and I will also present these ideas in a webinar on September 11 at 1:00 eastern time. I hope you will register and join us on the call.
To the best of my knowledge, this is the first paper of its kind. I hope it will stimulate a lot of discussion and that you'll share your thoughts with me here.
Posted by Jim Nail on September 5, 2007 at 05:49 PM | Email this post
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In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.
If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google."
That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA.
One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.
The "one click away" defense does not apply here. FDA says it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. In that case there is no need to provide that information on the same page that mentions the drug name and its indication.
Thus, an AdWord could be said to comply with the "one click rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary.
In "BAdwords," there is only a link to the product Web site, not the PI. Presumably, the user would have to find the link to PI once on the product Web site.
So, if there actually is a "one-click rule," it is not correct to invoke it for every kind of ad on the Internet, and surely not in cases where you really need TWO clicks to get to the PI or fair balance!
It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice. These ads are fleeting, here today, gone tomorrow!
For more on this and other "Tricks" see my post: Web 2.0 Tricks for Pharma Marketers to Be Revealed September 19 in Philadelphia.
Posted by: John Mack | Sep 6, 2007 1:36:37 PM
Thanks for your comments.
Agreed -- there is no "official" FDA one-click rule, nor do we say there is. But there is a "received precedent" that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it "best practice". Or call it just "common practice". In our paper we say that if you have a branded blog, social network, discussion forum, etc. have a link to the PI prominently n the navigation or other links on the site.
You raise some interesting points about search. We focused solely on the social media realm, not the "traditional" interactive realm. We only touch on other Internet marketing to make the point that marketers don't have to wait for FDA guidance to take advantage of new marketing forms.
That said, I agree. In a strict interpretation, paid search ads are probably verboten: given the space restrictions, there's no way to get any sort of "fair balance" statement into an AdWord ad.
But I think it is more complicated than that. I just Googled High Blood Pressure. A Lipitor ad pops us but only says, "Visit Lipitor.com to learn ways to lower your cholesterol." Click through and the first thing on the page is "Diet and Exercise". The second heading on the page is "Cholesterol-Lowering Medication".
I guess this is an example of one of the tricks you mention: within the confines of the AdWord text, they never make a claim or even explicity state the indication.
Are you saying that the act of buying the keyword and having their ad pop up is tantamount to including it as an indication in their ad? It would be interesting to do some consumer perception research: I wouldn't be surprised if the consumer walks away with the link between Lipitor and lower blood pressure, in which case there could well be a cause for the FDA to issue a warning letter.
Posted by: Jim Nail | Sep 7, 2007 2:26:20 PM
Jim,
This is a terrific piece and it's good to see you dealt head on with what I think is one of the toughest social media issues drug companies face - adverse events. I will be happy to share this with interested companies.
Posted by: Mike Spataro | Sep 17, 2007 8:43:51 AM
Thank you. There is good information in this white paper especially regarding FDA requirements for Pharma DTC.
Two comments:
(1) Now that this paper is published, any Pharma company that reads the report is implicitly responsible for being aware of potential FDA requirements for social media participation. [In reality, they are responsible for everything they do anyway.]
(2) I found this interesting quote from GlaxoSmithKline's pharma operations chief David Stout: "In the US, the media has ... had more of an impact on physician and patient impressions than the data itself."
[quoted in The IN VIVO Blog, July 27, 2007]
Posted by: Steven Maimes | Sep 19, 2007 4:59:27 PM
Good stuff.
It makes we wonder how your findings could apply to other industries -- finance, health care and security -- where free and open conversations are a little more problematic.
Posted by: Dan Greenfield | Sep 24, 2007 5:23:24 PM
I came across this link today http://www.tjkuhn.com/
It's a new blog that looks at good practices for the pharmaceutical industry from a qualit assurance perspective.
May benefit from your report
Posted by: Dan Greenfield | Sep 27, 2007 6:40:58 PM
