100 Years of Fortitude

J0202041 The FDA is celebrating its 100th birthday.  Like the FDA’s Critical Path Initiative (CPI) (see prior posting on this topic), this is an opportunity to get some messaging out there to support the agency.  However like the CPI, it appears to be a missed opportunity.  (Note, neither the 100 year birthday nor the CPI appears as a link on the FDA’s own Hot Topics Page, nor their opening Web page.)  There is a Centennial Home Page, but good luck finding it.  In the A-Z Index, it is not listed under Centennial. 

Most of the events associated with the Centennial are none too exciting.  There is very little to create an understanding with the public about the critical role the agency plays in every day lives.  There is nothing like a "virtual public health museum" created on their site to mark the event and to trace their origins or wide-ranging impact on our lives, or to trumpet some of the agency’s many successes.  From a communications perspective, this was an opportunity to leverage that success in the agency’s favor.

Instead, the FDA is holding a series of celebratory events, one of which occurs, starting yesterday and lasting through the 20th in Washington, D.C.  It is the FDA Science Forum.  One of those who was slated to speak is Acting Commissioner Andrew C. von Eschenbach – finally (see prior posting on this topic).  He was set to speak about the FDA for the 21st century -0ne hopes that during the next 100 years, he mentioned whether or not the agency will be acting on the Plan B fiasco – one of many FDA issues during the past year that have undermined the success of the prior 99.   If he didn’t address it, either then or soon, many inside and outside of Congress figure he can probably forget anything other than an "acting" career at the FDA. 

The event – "A Century of FDA Science:  Pioneering the Future of Public Health"  brings together the agency leaders and stakeholders.  Yesterday afternoon from 1:30 – 5:30, the agency sponsored a free public session called "Ask FDA".  While that is a generous four hour time period, given that they only sent out a press release about the session the day before it was to be given, many who might have come might have been otherwise engaged. 

However, if I had been there, which unfortunately I couldn’t be, I would have asked the following:

  1. How can companies best participate in the CPI and secondly (a two-for-one question) why should companies participate?
  2. How has Congress been supporting the CPI?
  3. Does the agency have a formal plan for addressing the serious erosion in confidence in the FDA on the part of policymakers and members of the public.  If so, what is it – if not why not?
  4. Why has the agency deliberately undermined its credibility with its non-credible position on the Plan B oral contraceptive RX to OTC switch?
  5. The COX-2 debacle forced a paradigm shift in the way that risk/benefit is assessed.  What should companies who designed and executed their clinical trials before this shift, do if they are having them evaluated and assessed after the shift?

If you happened to drop by and had the opportunity ask a question, please let us know what they said. 

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