Risk Management Committee Announced; Congressional Hearing Tomorrow

Yesterday the FDA announced the formation of the Risk Communication Advisory Committee – a new 15 member committee solely dedicated to

  • help FDA better understand the communication needs and priorities of the general public;
  • advise FDA on the development of strategic plans to communicate product risks and benefits; and
  • make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

Perhaps it is a sign of the times that the name of the Committee is the "Risk Communication Advisory Committee" but part of the charge is to craft both risk AND benefit messages.  Why then not call it the Benefit and Risk Communication Advisory Committee?  A Federal Register Notice will be published shortly seeking nominations for the committee.

Meanwhile the Congressional hearing on the FDA’s role in evaluating Avandia – Congressman Waxman’s Oversight Committee – will take place tomorrow.  A panel of five are slated to provide testimony –

  • Dr. Andrew C. von Eschenbach, FDA
  • Dr. Steven Nissen – Cleveland Clinic
  • Dr. Bruce M. Psaty – University of Washington
  • Dr. John B. Buse – University of North Carolina
  • Moncef Slaoui – GlaxoSmithKline

To say the least, it promises to be an interesting few hours.  One may guess that, like the name of the committee noted above, the focus will be on the FDA’s role in evaluting risk over their role in evaluating benefit. 

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5 Responses to Risk Management Committee Announced; Congressional Hearing Tomorrow

  1. Insider says:

    It’s John Buse.
    Cheers

  2. Mark says:

    Thanks, I made the correction. Appreciate the head’s up!

  3. Risk Management Committee Announced; Congressional Hearing Tomorrow

  4. WEL says:

    MAXIDEX WARNING
    I had eye surgery and in the post-op pack was MXIDEX(dexamethasone) drops by ALCON LABS.
    Two days later I was blind
    Use Google and enter EPOCRATES MAXIDEX to verify

  5. Arnab Majumder says:

    Sir can u please give me some information on the developmaent in the field of risk managment.
    Please sir kindly send me the information, then i will be highly greatful to you