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.     

So many people have been laser focused on the FDA's Part 15 Meeting on the use of social media to promote medical products being held this week in Washington, that the meeting on the same two-days of the Risk Communications Advisory Committee has gotten scant attention.  So let's pay attention, shall we?

While the agenda appears rather unremarkable and even uninformative, the content itself has much more to say about the directions of the FDA's thinking with respect to communication - and the outcome may have more immediate impact than that of the Part 15 meeting, the contents of which is going to take the FDA months to digest, much less act upon.

Specifically, the material from the FDA Transparency Task Force is going to present hypothetical emerging public health case studies that raise specific questions about how the FDA should react to the situation. 

For example:

State and local public health authorities have been investigating an outbreak due to a foodborne pathogen. There are 18 illnesses primarily in one state with a few in a neighboring state. According to the human laboratory data, the same strain of pathogen caused all of the illnesses. One individual has died. The epidemiological investigation by the states found sandwiches and salads in common but no epidemiologic study is underway yet to implicate a specific food item.

• Should FDA communicate this outbreak to the public? If so, what should the agency say? Is there anything that should not be communicated?

• Should the population that may be potentially exposed to the pathogen affect whether, and when, a message should be communicated?

• How should FDA effectively communicate to consumers as the investigation evolves and new information changes the picture?

The answers to these questions are going to provide a great deal of insight into how the FDA is going to approach outbreaks in the future and could provide guideposts that will better inform industry (frankly - food, device and drug, even though it is a food example) of the parameters and tripwires that will be used in the future for communicating to the public. 

Consider the next hypothetical as well:

Second Hypothetical Case Study: Early Communication about Emerging Safety Issues about FDA-Regulated Products

(Note: Because the purpose of the discussion is to elucidate the policy considerations that should be weighed in deciding whether changes to current practice, laws, or regulations are warranted, the issues should be discussed without regard for the current practice, laws, or regulations.)

• Should FDA advise the public about this outbreak? What are the factors that should be considered in deciding whether to do so? Is there anything that should not be communicated?

• If the agency communicates to the public about the outbreak, what message should be communicated to consumers? What geographic area should be covered?

• Should FDA communicate to members of industry whose products may be implicated in the outbreak? If so, what is the message?

• Another entity, based on its own analyses, believes the outbreak is due to another fruit and releases a public statement to that effect. How should the agency respond?

This discussion will shed a lot of light as to how the FDA may work with industry in the future surrounding a problem with a product.  Until now, FDA has had to be sensitive to how closely the agency works with industry out of concern that the FDA could fall victim to charges from policy-makers and consumer groups that it is playing ball with industry rather than regulating.  Getting answers to the conditions of this hypothetical could give the FDA more cover for working more closely with industry to resolve outstanding issues, protect the public health and to get more hands on deck in a time of emergency.

As blogging evolved, more and more corporations have begun corporate blogs as a means of engaging the public in dialog.  Pharmaceutical companies, representing a highly regulated industry, has been much more reticent and cautious in participating in this medium.  Meanwhile, healthcare is one of the primary reasons that people go to the Internet for information.  It is another example of how over-regulation of the communications of the pharmaceutical industry might have a negative impact on public health rather than a positive one because the entities that conduct the research and collect the data on the products we ingest are inhibited from direct communication with the public out of fear of regulatory repercussions.  Yet others who might and do spread misinformation and sell snake oil are free to do so.

Recently, however, on the near-eve of the FDA's Part 15 meeting on Social Media and Medical Product Promotion - a meeting that may well determine a change in FDA regulatory policy - a major pharmaceutical company has begun a new corporate blog.  The blog is AZ Health Connections by AstraZeneca and it follows in the wake of two other corporate blogs - JNJBTW by Johnson & Johnson and GSK's More Than Medicine.

In setting up their blog, AZ has done a few smart things.  They have a very detailed comments policy that was obviously put together by a fleet of lawyers.  They state that they reserve the right to edit or not publish some comments.  They also state that this blog is not the place for discussion of specific product issues.  But the smartest thing they did in my mind is to provide referrals for people if they do want to report a problem with a prescription product.  That is smart because at some point in the future, companies are going to be compelled to be more aggressive and proactive in adverse event reporting - so why not start now?  It is also smart because it reinforces the message that the blog is a platform for other discussion.  There is also an elaborate "Legal" tab.    

There is a primary editor for this blog - a Senior Director in AZ's corporate communications division, though it is unclear whether there have been different authors for the postings there so far.  A visible indication of possible multiple authors is the fact that the postings each have different fonts and spacing, indicating that they were drafted in Word somewhere and cut and pasted into the blog without stylizing consistently first.   AZ indicates it is their desire to engage with the blog, but the early postings leave little upon which to engage.  For example, their posting on the Part 15 Social Media Meeting is purely informational about the meeting, but doesn't provide a point of view of what AstraZeneca would say to FDA, either at the meeting or in comments posted to the docket.  Without that kind of substance, it is hard to engage.  But it is early yet, and this blog, like all blogs, needs time to find a voice and identify its parameters.  

Anyone in the pharma biz, and particularly the communications biz, is aware that on November 12 and 13, the FDA is holding a Part 15 meeting to gather input regarding the regulation of promotional communications through social media.  The meeting begins a slow and laborious process that will last an unknown length of time that will hopefully result in some kind of guidance from the agency by which time the landscape of social media will have probably changed dramatically since the holding of this meeting and the closing of the accompanying docket. 

With a two day meeting and what will predictably be a very crowded docket, the length of time that the agency takes to digest all the input may be very long.  No one knows. 

The meeting is being held in Washington at the National Transportation Safety Board (NTSB) and registration for attending and speaking has been closed.  The FDA is going to provide a Web stream of the proceedings and will post instructions to the meeting information site. 

I decided early on not to apply for a speaking slot because I felt that the slots were best reserved for the real stakeholders - the search companies like Google and Yahoo and the pharmaceutical companies and to legal and regulatory experts.  While we bloggers certainly have lots to say, we aren't stakeholders. 

That said, we are media.  And I will be attending the meeting and reporting with regular updates from the meeting on my Twitter-feed as well as providing up-to-date postings on the blog.  In addition, I plan to take my Flip Cam and will record interviews with willing participants as the day goes along.  I also plan at the end of the day to post key takeaways.  I will post the videos to the blog and to my YouTube channel.  So for those who want my take on the day, follow me here on the blog or on Twitter and I'll be giving you my feedback and analysis of the two days.

Last week, the FDA sent a warning letter to Procter & Gamble, presumably the same one that was posted a few weeks before by the agency, and then retracted.  Well, it is either back, or we are all experiencing a profound sense of Déjà vu.    In fact, the FDA's press release states that they are the same ones that were mistakenly posted on October 14 due to computer error.   (Really, the computer did it?)  

The targeted products were Vick's Dayquil and Nyquil both with vitamin C added.  The reason?  According to the release the reasoning was:

• To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
• Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

While technically accurate, it does seem odd when you stop to think that a HUGE percentage of people who get a cold start beefing up their Vitamin C.  So why not offer a product that does it for you and relieve the consumer of a little pill burden.  Well, the reason is that the FDA has said Vitamin C is not effective and expressed that in several Warning Letters previously.  

It is one of those cases, of which there are a growing number (like the action against paid search), where regulatory action is taken to keep a company from doing something that does not comport with the true reality of consumer uses.  Still, the FDA does have to protect the integrity of the process and, where it has said Vitamin C is not effective, stick to the story.

And the vehicle of a Warning Letter was probably based on the fact that the release states that the agency has enunciated this principle in prior Warning Letters.  Though they are not cited in the release, they are cited in the Warning Letter to P&G.  Some of these were recent and some went back to 2001.

A few thoughts on this.  Warning Letters are reserved for issues that involve matters of true public health concern.  This obviously does not qualify in that regard since most consumers are popping Vitamin C during a cold as frequently as aspirin.  But they are also issued when there is an issue that has been around for a long time and people don't seem to be getting the point.  

So the takeaway lesson here is that it pays to examine and analyze Warning Letters as they come take away key findings that companies use to integrate in their own planning and to use to re-evaluate its own activities and product marketing for risk exposure.  That is one of the many reasons, Eye on FDA supplies you with quarterly overviews of Warning Letters.  Speaking of which, we are due for one later this week.