Thursday, November 05, 2009

My FDA Social Media Hearing Presentations

As you no doubt know, FDA is hosting a public hearing on pharma's use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here):
  • 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA)
  • 10:20-10:30 AM on Friday, Nov 13
You can find my presentations here (warning: BIG pdf files):
  • Part 1, covering FDA issues 1 (Accountability) & 2 (Fulfilling Regulatory Requirements)
  • Part 2, covering FDA issues 3 (Posting Corrective Information) & 5 (Adverse Event Reporting)
These presentations summarize most of the results to date of the ongoing survey I have been running since 20 September 2009 (find the survey here). The survey includes all 19 questions for which FDA seeks answers. There were 354 respondents as of 1 November 2009.

Some key points I will make include:
  • Media agnostic regulations are not popular among industry experts.
  • The “One-Click Rule” is desired by the industry. However, most often it takes two clicks to reach the approved labeling (PI). Since the PI is virtually unreadable, there needs to be a better way to provide the fair balance regardless of the number of clicks!
  • There are some ideas for dealing with space limitations imposed by certain social media apps.
  • DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible.
  • Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]
  • Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should be REQUIRED to do so only for sites owned or directly sponsored by them.
  • Vast majority of “Adverse Experiences” reported on social media sites do NOT meet the requirements for AE reporting.
  • Although there are monitoring tools available, the resources required to monitor all social media sites for adverse events are not justifiable.
  • Consequently, few companies have standard operating procedures for processing adverse event information from social media sites.
  • However, pharma companies can help consumers report adverse events directly to the FDA using social media tools such as widgets placed on Web sites.
  • Some innovative ideas for fulfilling regulatory requirements to submit social media promotional materials to FDA were suggested, including:
    • Register sites with FDA for agency to monitor
    • Submit “template” (design and/or sample content) of social media site to FDA for pre-approval/approval
  • But there was no consensus opinion about satisfying regulations regarding submission of social media promotional materials.
  • Too stringent regulations will prevent companies from carrying on two-way social media conversations with consumers and HCPs. Such conversations can have a beneficial impact on public health, especially when clarifying or correcting misinformation.
While I am in favor of some new and relaxed FDA regulations/guidelines regarding pharma's use of social media, I am also in favor of HIGHER standards, the development of which should be a collaborative effort among all stakeholders. That is, FDA regulations merely define the BASEMENT level best practices that pharma needs to adopt for effective use of social media. I believe there is a need to look beyond the FDA and start building the FIRST & UPPER FLOOR level best practices. More about that in later posts.

Right now, all eyes are focused on the FDA. No matter what guidelines the FDA comes up with, I will continue to "out" pharmaceutical marketing worst practices on this blog.


  1. Anonymous4:58 PM

    I'm with the FDA and you should save your travel money. This survey means nothing.

  2. Is that you, FDA Intern?

    Funny, Jean-Ah Kang, special assistant to DDMAC director Thomas Abrams, specifically invited me to submit a request to make a presentation after I described the survey. I don't suppose you work for her.

    BTW, I never take advice from anonymous commentators.

  3. John,

    You do not need to respond to that posting, it does not have the necessary details to be considered an adverse event to your Blog. :-)

    The "employee" can call the 1-800 number instead.

  4. An Anonymous commentator on a blog? C'mon now Mr. or Ms. Anonymous. Don't you know you just broke the social media rules... Oh that's right, that is why you are seeking social media guidance in the first place, isn't it?

    If you can't identify yourself on a blog, you have no place commenting.

  5. Brad,

    Love it - "adverse" blog comment does not rise to level of "respondable adverse comment (RAC)" unless it meets these 4 criteria:

    1. reporter identifies him/herself
    2. reporter is not an ahole
    3. comment has some merit
    4. I care

  6. John,

    Thanks for sharing your presentations in advance. They'd better take into account the survey results. For the patients' sake.

    On the other hand, to take the coming FDA guidelines as a basement and start building on the top it's an excellent idea. I have always defended self-regulation because I detest paternalistic approaches.

  7. Anonymous12:14 PM

    Being from FDA, I can't identify myself... but social media is hardly a priority in DDMAC's shop. Jean is very nice and when you begged to present she had no option but to be cordial and ask you to present (so we can all laugh behind closed doors). If they want to consider this so-called "data" you think you have, then they will want to see the methodology and how you prevented responders, like yourself, from completing it numerous times. I'm not trying to be negative, but the agency is "science based." Would you like them to approve a drug based on anecdotal information from a website that says "yea... sure the drug works." If you don't want anonymous comments then remove that option.

  8. I didn't say I don't want anonymous comments - I said I dont take advice form anonymous commentators. You FDA people need better reading skills, it seems.

    I make no pretense that this is a 'scientific" study. I also use some technology that prevents more than one entry per person. That's hardly a problem -- who would go through all the trouble to bypass that?

    More important than the quantitative "votes" are the over 500 qualitative comments and ideas that were also submitted. I doubt that the FDA will get as many comments as I have.

    BTW, I will submit all these comments to the docket.

    Finally, I dont care a fig if the FDA pays attention to this information or not. The more important audience is the public. Why don't you go back to your office and have a nice laugh about that?

  9. John,

    Can you just get the IP address of the 'anonymous' post to confirm it comes from the FDA?

    Your hosting company can help if you don't know how.

    You should even be able to identify the machine it comes from and reveal this to the audience on presentation day.

    Shoot us an email if you need tec help with this.



  10. Vertic,

    Thanks for the offer. Send a note to so we can discuss his.

  11. Anonymous1:30 PM

    Save your time. You guys are funny. you caught me red handed. so I'm not with the FDA... I'm just jerking your chain a bit. I enjoy reading your posts though, otherwise I wouldn't be on here. Good Luck next week.

  12. Don't worry, I have no desire to track down the identities of anonymous posters even if I had the technical savvy to do so. I may, however, stop the discussion if it gets too boring ;-)


Related Posts Plugin for WordPress, Blogger...