Modelling a Meeting - The Food & Drug Advisory (FDA) CommitteeBelow you can download
A 23-page "Report of a Pilot to Explore the Use of Information Modelling of FDA Advisory Committee Transcripts as a Tool for Optimizing Messages at Future Meetings".Summary of Results
Prepared by Louise Oram and James Lawley of 9CQ Limited, 2 August 2004
In total 59 people participated in the two-day meeting. The verbatim transcript of the meeting ran to 737 pages!
The Food and Drug Advisory Committee meeting of 26 and 27 February 2004 included presentations by the FDA, Hoffmann La-Roche and Generic firms. Our analysis shows that Information Modelling can provide information outside that normally available to personnel preparing for an FDA Advisory Committee meeting. In particular 9CQ established that:
Over 50% of questions asked of the Sponsors were not answered or were only partially answered. This suggests inadequate preparation both in terms of content and being able to respond to the wide variety of ways Committee members format their questions. Very often these were complex, disguised or ambiguous, and sometimes attempted to lead or restrict the answer.
The Hoffmann La-Roche representative apparently antagonized FDA staff, and repeatedly misunderstood or did not address questions put by Committee members. Also, an unconscious language pattern of his may have had a detrimental affect on how his presentation and answers were received.
We could find little evidence that Sponsors utilized individual linguistic preferences and styles when replying to Committee members. They therefore missed opportunities to build rapport and credibility.
The Committee Chair’s personal views seriously impeded his ability to remain unbiased in his chairing of the meeting. Added to that, it wasn’t until 90% of the meeting had taken place that the FDA revealed certain options they had asked the Committee to consider were “not an acceptable course of action.” These incidents may have endangered the integrity of the whole Advisory Committee process.
Poor chairing meant that some member’s suggestions were lost, pivotal scientific data from a Generic firm was ignored, and there was often confusion over what was being discussed at any moment.
Our analysis identified who said the most and who said the least. While certain Committee members, voting Consultants and FDA staff made many more contributions than others, the Chair dominated the meeting. Excluding pure chairing activities, he made five times as many contributions as any other Committee member.
Detailed analysis with verbatim examples are given in the full report Info Modelling Report v3edit.pdf
which can be downloaded below.