#FDASM: + ca change, + c’est la meme chose

November 12, 2009 · Filed Under general · 16 Comments

The FDA is holding a public hearing on the “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” There is a tremendous amount of buzz on Twitter and blogs about this meeting which will hear 60 speakers, some more than once. As ABC News Business division reports this morning “Drug Industry Presses FDA to Allow More Online Ads.” Funny they would try that on the same week we learn that close to 1/3 of all published articles about clinical trials do not mention certain side effects known to the principal investigators! Of course the ads are only a portion of what will be discussed at the FDA hearing. There are 5 questions that will be discussed:

For what online communications are manufacturers, packers, or distributors accountable?
How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
When is the use of links appropriate?
Questions specific to Internet adverse event reporting

To start and to put you in the right mood, you should know that this official meeting about social media will take place in an office without any cell or internet access! Unlike any of the conferences that people attend every day, there will be no real-time reporting, no tweeting from within the room. As my old buddy John Mack wrote recently

This reminds me of the Cary Grant movie His Girl Friday where reporters in fedoras rushed out of the courtroom and ran to the press room to call in their stories. There is a press room just outside the hearing room at the NTSB Center, but I haven’t been able to determine who can use this, what facilities it has, and why I would want to be holed up in there when all the action is happening up front in the court of public opinion!”

In the age of Web 2.0, Health 2.0 and user-generated content, the Federal agency in charge of the regulation of the entire medical and pharmaceutical industry will hold this historical meeting about social media and therefore user-generated content with one individual consumer representative (Kim Witczak, whose husband committed suicide after taking Zoloft for five weeks). You heard me right. Most of the 58 other presenters have commercial interests that could suffer irreparable consequences from the effects of future FDA regulations of medically related social media resources. They range from representatives of pharma companies and PR firms to pharma communication consultants and newsletter publishers. There are many representatives of Health 2.0 commercial companies. So, as happens almost every time in Washington, there will be no direct representation of the voice of the patient. In other words, the voice of the patient will be marginalized, as always seem to happen in the Capital city.

Tags: Abc News, Business Division, Cary Grant, Commercial Interests, Communication Consultants, Consumer Representative, Courtroom, Fda Regulations, Girl Friday, Hearing Room, John Mack, Media Promotion, Media Resources, Media Tools, Medical Products, Mobile Technology, Ntsb, Patient Representative, Pharma Companies, Pharmaceutical Industry, Pr Firms, Principal Investigators, Public Hearing, Real Time Communications, Regulatory Requirements, Space Limitations, Submission Requirements, Twitter, Using Tools, Witczak

Social media and healthcare: hospitals lead

September 28, 2009 · Filed Under Why PM, e-pts resources, hc's problem list, policy issues, trends & principles · 8 Comments

A signal moment has happened: When a major business authority with no history in healthcare speaks up about a shift in the wind, it’s worth noting. And this time it’s a great sign for participatory medicine, because the news is that hospitals are engaging with patients.

rohit My company’s been working with hospitals the last few months, and it’s surprising and hopeful how eager they are to use social technologies. Last week social media visionary Rohit Bhargava at Olgivy (see Wikipedia page on social media optimization) wrote on Ogilvy’s blog about how hospitals have been “quietly innovating with using social media without receiving much attention or credit for it.”
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