Answers
12/07/1992

<TITLE>FDA RECEIVES IOM REPORT ON ADVISORY COMMITTEES</TITLE>
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T92-67                                             Betsy Adams
Dec. 7, 1992                                       (301) 443-4177

               FDA RECEIVES IOM REPORT ON ADVISORY COMMITTEES

    The National Academy of Sciences' Institute of Medicine (IOM) has         
completed a study on the operation of FDA's advisory committees, which IOM    
conducted at the agency's request.  Advisory committees are groups of         
outside experts convened by Federal agencies to make recommendations on       
agency actions.  The report constitutes a scholarly, detailed source of       
information about FDA's advisory committee system that will be useful to      
those inside and outside of the agency.
    The report confirms that the existing system is fundamentally sound, has  
served the agency well and does not need major adjustments.  It also          
recommends a number of administrative and procedural changes to streamline    
the performance of the advisory committee system and increase its usefulness.
    The following may be used to respond to questions:
    FDA commissioned the IOM study to help identify ways to improve the       
process of selecting expert members for advisory committees and using their   
special talents to aid in decisionmaking on drug, biologics, and medical      
device approvals.  In compiling its report, the IOM group interviewed         
current and former advisory committee members, FDA officials and industry     
and consumer representatives, and reviewed current FDA procedures.
    In its report, IOM acknowledged the complexity of the issues studied -- 
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                                            Page 2, IOM Report, T92-67
in particular, the problems associated with real or perceived conflicts of    
interest.  FDA has found it increasingly difficult in recent years to         
identify potential committee members with needed expertise but without        
financial interests or professional ties that could result in conflicts or    
the perception of conflicts.  This problem is not unique to FDA, but applies  
to other agencies that have advisory committees.  Therefore, FDA asked IOM    
to come up with criteria to use in recruiting advisory committee members      
while maintaining both real and perceived impartiality in advisory committee  
deliberations.  
    The IOM group explored ways such conflicts could interfere with the       
integrity and impartiality of committees.  While stressing the need for       
using definite criteria in granting waivers to potential committee members    
-- allowing them to serve despite the possible appearance of a conflict,      
when their special expertise is considered indispensable -- the report does   
not contain specific recommendations on what these criteria should be.  FDA   
will be working to devise criteria for permitting these waivers.
    While the IOM study has been going on, FDA has been conducting its own    
internal management analysis.  The results of FDA's review of the report and  
the agency's own analysis have led FDA to concur with nearly all the          
report's recommendations.  The agency expects to implement most of them in    
the near future.  It has already taken steps to get materials into the hands  
of committee members earlier to allow more time for review prior to a         
meeting, and also plans to implement training for new members and establish   
regular meeting dates on an annual basis.
    FDA acknowledges the tremendous efforts of the IOM committee chair, Dr.   
Lawrence Earley, and its members -- experts in science, law, and public       
policy.  The report will serve as a valuable tool in helping FDA streamline   
the system to ensure that the agency receives the best advice in its          
decisionmaking.
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