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Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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A Resource Implications
Pages 215-221

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From page 215...
... The analysis is preceded by a brief discussion of the costs of the current system. CURRENT SYSTEM COSTS UNDERESTIMATED Each year, the FDA prepares an Agency Summary on the fiscal year costs of all of its advisory committees, in compliance with the requirements of the Federal Advisory Committee Act (FACA)
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From page 216...
... - ~ as: my o, - ~ ct c)
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From page 217...
... that provides support services to its device advisory committees. Also excluded are the staff of the Division of Ethics and Program Integrity who process conflict-of-interest waivers, and the FDA's Committee Management Office, which prepares the annual report on advisory committees.
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From page 218...
... in each center will be needed to perform the day-to-day responsibilities of recruiting (including routinely soliciting ideas for potential members from current and former advisory committee members; professional medical and scientific societies; medical school deans and department chairmen; and industry, consumer, and patient organizations) ; contacting appropriate professional journals; using the NIH-ADAMHA computerized file; and communicating with potential committee members to increase their interest in serving on a committee.
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From page 219...
... Factors affecting costs include the frequency of orientation sessions, the specific FDA staff who will participate when and where the sessions are held, and what training methodology is used. If the FDA adopts the IOM recommendation to hold two or three orientation sessions in Washington, D.C., per year, separate from any scheduled committee meeting, new advisory committee members must make an additional trip to Washington.
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From page 220...
... 4. Scheduling Advisory Committee Meetings in Advance; Renewing the NDA and IND Pipeline Annually The IOM committee recommends that the FDA establish a meeting schedule for each committee one year in advance.
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From page 221...
... Rate per Day Costs $150 250 320 $480,000 800,000 1,024,000 lathe FDA's regulatory responsibilities are vast and the expertise needed to effectively carry them out are equally great. It is neither feasible or desirable to eliminate the use of advisory committees as a way to acquire some of that expertise.
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Key Terms

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  • incremental costs
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  • professional staff
  • management staffs
  • policy guidance
  • scheduling advisory
  • five recommendations

  • provide management
  • cber payments
  • committee recommendation
  • computerized file
  • cdrh costs

  • procedural changes
  • nih project
  • incur additional
  • estimated cost
  • former advisory

  • public information
  • additional monies
  • department chairmen
  • scheduled committee
  • calculated relatively


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