The FDA has scheduled a public hearing for November 12-13, 2009. The FDA is seeking public feedback on “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” (see “Let’s Respond to FDA’s Questions Regarding Its Regulation of Social Media“).
The FDA has requested for feedback on 19 particular questions (see link above). I’ve compiled all of these questions into a survey to help kickstart the discussion. (here), which I hope will assist you in developing your own remarks for submission to the FDA while also allowing you to see what others have to say.
- To enhance the conversation, I’ve created the hashtag #fdaSM on Twitter. You may participate in the Twitter conversation. here.
- You can also join in on the live chat or listen to the podcast archive: “Meet Digital Pharma’s Faculty: What’s Hot and What’s Not?“
In this post, I’d like to start a discussion about the FDA’s first question: What parameters or criteria should be used to determine when third-party communications taking place on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?
I suggested a couple of parameters in the survey that I thought were relevant to this question:
- A marketer or agent paid for an ad on the page to be displayed based on the page’s content (eg, Google Adword on content sites)
- The content was paid for by a marketer or an agent (eg, paid blogger or Tweeter to write about product)
Keep in mind that I only included these options in the survey as a starting point. If you have any others, please let me know in the survey’s remark section or in the comments section of this page. I’ll then include these as extra parameters for survey respondents to vote on.
A related concern is how firms should declare their engagement or influence over debates or material, particularly on third-party sites.
- Among the possibilities are:
- Only when content is paid for is disclosure required.
When feasible, disclosure should be prominently posted alongside pertinent content.
When a marketer pays for an ad to show alongside user-generated content on social network sites that permit advertising, it’s easy to tell. As is customary, such advertisements should be labeled “advertisement,” as are the advertisements on this blog page.
Of course, unethical sites may not contain the warning, and it is then up to the reader to determine whether the information is a sponsored advertisement or not, especially if it is phrased and formatted to appear like content. This issue was long ago examined by the in what appears to be a galaxy far, far away. Internet Healthcare Coalition (no disbanded), which developed the eHealth Code of Ethics.
The second element – paying someone to generate information in a social media setting — clearly demonstrates “substantial” influence over the content. Not providing this information adds insult to injury. This has undoubtedly occurred in the past and may continue to occur. Example can be found here: “Alli Ad Campaign Promises Honesty, But Does It Deliver?”
Although I cannot prove it, I have a strong suspicion that there are paid agents of the pharmaceutical industry out there posing as consumers or patients on social networking sites and posting statements that are simply marketing messages.
The FDA may only give guidelines stating that any such messages from paid agents should contain a disclosure notice stating that the person writing the message is an employee of a pharmaco or an agency contracted by a pharmaco.
No one will know for certain when such a guideline or regulation is broken, but if a breach is ever discovered — for example, by an investigative reporter — the FDA may take action. More significantly, as with their privacy policies, every pharmaceutical business should establish its own standards on such concerns and make them PUBLICLY available.
Consider this: FDA advice should include a statement stating that each pharmaco must have an SM policy that includes a transparency notification… yadda, yadda, yadda, yadda [YOU CAN PROVIDE THE DETAILS HERE IN THE COMMENTS TO THE SURVEY]: http://bit.ly/GgW14]
- Wining and Dining Bloggers (see “Thank You Johnson & Johnson for Dinner” and “Bloggers Dining at Pharma’s Table“).
- Patient Testimonials. See “Alice, 35, is Not a Real Ambien CR Patient.“
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