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1991.06.12 :  Reorganization of FDA

Contact: Donald C. McLearn (301) 443-1130 (Home) -- (301) 926-
6909
June 12, 1991

       HHS Secretary Louis W. Sullivan, M.D., today announced a
reorganization of the Food and Drug Administration that
streamlines senior management at the agency, designating five
senior managerial positions which report directly to the
commissioner.  The positions include four new deputy
commissioners and one senior advisor under FDA Commissioner David
A. Kessler, M.D.
        "The Food and Drug Administration must be able to carry
out its vital role of protecting American public health,"
Secretary Sullivan said.  "With the management changes we are
announcing today, the FDA can respond more effectively to the new
challenges and responsibilities that confront it."
        The reorganization places the responsibilities of the
agency under five senior level managers:
        Operations -- Headed by a deputy commissioner for
operations, this office will handle day-to-day management of the
principal FDA centers including Foods, Drugs, Biologics, Devices
and Radiological Health, and Veterinary Medicine.  The operations
office will also manage all of FDA field and regulatory affairs
offices.
        Policy -- Headed by a deputy commissioner for policy,
this office will oversee all FDA regulations development, ensuring that 
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new regulations are written and issued promptly.  This office would
also be responsible for blending FDA regulatory policies with those
of other countries and governments.  
      Management and Planning -- Headed by a deputy commissioner
for management and systems, this office will oversee and streamline
the management systems in the agency.  
      External Affairs -- Headed by a deputy commissioner for
external affairs, this office will deal with Congress, consumer
groups, trade organizations, health groups, and the press.  
      Science -- Headed by a senior advisor for science, this
office will advise the commissioner on scientific matters and
oversee the National Center for Toxicological Research, Orphan
Product Development, AIDS Coordination, and Biotechnology.
      James O. Mason, M.D., HHS assistant secretary for health
and head of the U.S. Public Health Service, said the reorganization 
will help bring about Secretary Sullivan's goal of more vigorous
management of FDA under Commissioner Kessler."
      FDA is one of the eight health agencies under the Public
Health Service within HHS.


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