What If FDA Threw a Party and No One Came? BioPharma Participation in the Part 15 Social Media Meeting

Don't be mislead.  A lot of people are coming to the FDA's Part 15 meeting on the use of social media in medical product promotion.  But will the ones who count be speaking?

This meeting has the potential to be a game-changer, and when there is a game-changer, we do well to put the event into perspective – how did we get here?

  • 2006-2009 – Internet use in general expands dramatically, particularly for healthcare.  But in particular, use of social media and the importance of social networks for conveying healthcare information and reaching targeted audiences simply explodes, with growth in use of Twitter and Facebook reaching breath-taking numbers.
  • January 2009 – Digital media, long ignored by the FDA's regulatory body, begins to beg new regulatory questions.  In the absence of any regulatory guidance by the FDA, urban myths such as the "one-click rule" take hold and become a defacto regulatory principle – that risk information that is just one click away is an acceptable form of promotional marketing communications.  While the FTC has produced a guidance supporting this notion, the FDA has not and to date, has said nothing about digital media that is noteworthy.
  • March 2009 – The FDA, in a podcast, finally begins to address the issue by stating that with respect to digital communications – "it is not the medium, it is the message".  This broad statement is meant to convey the notion that if you follow current regulatory principles, it does not matter what communications medium you use.  You simply cannot leave out risk informaton, promote an unapproved use or communicate without fair balance.  This broad enunciation of policy fails to address the countless instances of nuance that are apparent in the way people use the Internet to get healthcare information, or the way that companies are currently doing it, i.e relying on the wobbly "one-click" rule.
  • April 2, 2009 – Rather than enunciating rational policy that would be specific about the failings of this perceived rule, the FDA in a single day unleashes 14 Notice of Violation letters to companies, covering 45 brands, for employing the one-click rule with paid search ads that convey risk information a click away.  (Note this is not unlike having the risk information in a magazine ad that continues on the following page in volumes of copy that, by the way, no one ever reads, but which the FDA insists on even though there is no evidence of any public health benefit to this practice whatsoever.)  The result is that medical product companies pull their paid search ads.  Nature, hating a vacuum, sees them filled by conveyors of products not regulated by the FDA, but which sell to patients with the hopes of cures and treatments. 
  • May 2009 -  Further evidence that the FDA has failed to perceive the communications movement that is underway, the agency issues a draft guidance on risk communication.  The draft guidance mentions the Internet just once. 
  • September 2009 – In a stunning reversal, perhaps brought on by the new leadership at FDA representing an Administration that is emblematic of digital media savvy, the FDA announces a Part 15 meeting to gather information upon which they would presumably gain insight for the eventual enunciation of policy, perhaps through a draft guidance.  The process is lengthy, involving two days of meetings, a docket to collect public comment that is open until February 28 and then long months of digesting that content and perhaps devising a draft guidance.  In public statements, the FDA now sites this as a "priority".  
  • November 2009 – The two days of meetings are scheduled for Thursday and Friday, November 12 and 13.  Registration to the meeting was closed due to an overwhelming number of sign-ups. 

So we are at the cross-roads of a game-changer.  But when one examines the roster of speakers who are slated to present at the meetings, one might be disappointed.  There are a few trade association groups representing the medical products industry.  There are only four pharmaceutical companies participating. 

One would think that at least the recipients of the 14 Notice of Violation letters might have something to say about their receipt and the current environment.  Or, maybe that the 18 or so medical product companies that have Sidewiki's attached to their home pages which raise significant strategic and regulatory questions, might show up to seek some answers.  Are they under a duty to seek out any adverse events that are reported there?  Are they under a duty to correct misinformation such as the promotion of off-label use?  People have argued either way on this, but only one opinion matters – that of the FDA.

The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren't the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice – the medical products industry.  Not their vendors or observers.  

One hopes that there is a more robust representation by the pharmaceutical industry in the docket.  Otherwise the concern voiced by many over these past few weeks – if the FDA enunciates a bad policy, wouldn't it have been better to have no policy at all – may step closer to being a reality, and industry will have missed an opportunity to shape a better policy.     

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