Twitter Updates

    follow me on Twitter

    My Profile

    • EXPERTISE -
      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

    About This Blog

    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

    My Favorite Dogs

    • January20063_005
      Nick and Nora

    Stats

    • eXTReMe Tracker

    Eye on FDA edrugsearch blog ranking

    • Healthcare 100

    Syndication

    « Weekly Roundup - 7-13-07 | Main | What's at Stake with Formal Dispute Resolution »

    July 16, 2007

    TrackBack

    TrackBack URL for this entry:
    http://www.typepad.com/services/trackback/6a00d83451bf5969e200e009930f768833

    Listed below are links to weblogs that reference A Look at GSK's alli Blog:

    Comments

    John Mack

    Mark,

    GSK and the Alli blog folks are to be commended for this blog, which allows anyone to submit comments. I have seen several negative comments and have even posted one of my own.

    There are also several comments from All team members, who clearly identify themselves as such.

    The ability to do all this is made possible by the lack of FDA regulation in the OTC market. There is no need, for example, to report adverse events. Therefore, it is easier for GSK to allow comments from anyone and to monitor these comments -- and thereby LEARN from their consumers.

    Mark Senak

    John, I agree it is commendable. I realize that there is no need to report AEs for an OTC, but it would still be possible for someone to comment on an AE for another GSK drug. What I meant to do was draw the contrast between one pharma that is putting up a blog, while other pharmas are afraid to even read one. Thanks John!

    Mark

    John Johnson

    Mark, a question on the monitoring of blogs:

    I know there are "regulatory clocks" for reporting serious adverse events (SAE) to the agency within a certain time after receiving a report for them. But doesn't "receiving a report" involve having the investigator/physician file a (perhaps brief) narrative? Does seeing a report of an adverse event on a blog, which is an unverified and unreliable source (as far as adverse event reporting goes, at least), really "start the clock" on reporting? I shouldn't think so, because anyone with a $100 computer and a $5/month net connection can start a Google blog and post "OMG Prozac gave me a heart attack!"

    To me, monitoring blogs and finding adverse effects (whether directly treatment-related or ancillary) offers the best of both worlds -- to have a heads up on potential/possible adverse effects but not have to report them officially.

    Mark Senak

    John,

    Thanks for the comment and yes, what you say makes a great deal of sense to me. But regulatory folks often feel most comfortable taking the most conservative point of view along these lines, and that pharmacovigilence must be factored in at the suggestion of an SAE. Frankly, I think this is still a developing area. - Mark

    Chubby Girl

    I've been blogging about Alli since the first day I started.

    Chubby Girl

    Check it out:
    MyAlliBlog.BlogSpot.Com

    Verify your Comment

    Previewing your Comment

    This is only a preview. Your comment has not yet been posted.

    Working...
    Your comment could not be posted. Error type:
    Your comment has been posted. Post another comment

    The letters and numbers you entered did not match the image. Please try again.

    As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

    Having trouble reading this image? View an alternate.

    Working...

    Post a comment

    Subscribe / Email Me

    Enter your email address:

    Delivered by FeedBurner

    Search

    • Google

      WWW
      eyeonfda.com

    September 2010

    Sun Mon Tue Wed Thu Fri Sat
          1 2 3 4
    5 6 7 8 9 10 11
    12 13 14 15 16 17 18
    19 20 21 22 23 24 25
    26 27 28 29 30