Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

NOTE TO CORRESPONDENTS                 Stephanie Schwalbe         
October 25, 1996                       (301) 827-6242


VICE PRESIDENTIAL AWARD PRESENTED TO FDA's DISTRICT OFFICE AND
MERCK & COMPANY, INC.

     Two teams -- one from the Food and Drug Administration's
District Office in Baltimore, and one from Merck & Co., Inc. --
will receive on Oct. 28 Vice President Al Gore's Hammer Award for
their contribution to the record approval for a significant new
treatment for AIDS.
     The teams' close cooperation in field inspection and in
review of manufacturing and testing protocols made possible the
approval for CRIXIVANŽ, a protease inhibitor, in 42 days, FDA's
fastest approval time for an AIDS therapy.   
     The Hammer Award is given to employees who have advanced the
President's National Performance Review by putting the public
citizen first, empowering their employees, and getting back to
basics.  It was presented to the Baltimore District Office and
Merck & Co., Inc. by Robert Stone, head of the Office of the Vice
President, National Performance Review.
     "The most important performance gauge in the pharmaceutical
field is the speed with  which important new drugs are determined
to be safe and effective, and made available to patients who need
them," Stone said at the award ceremony in Elkton, VA.  "The 
approval for CRIXIVANŽ set a new standard for AIDS therapies -- 
drugs whose FDA approval times were already the fastest in the
world."
     The key element of the speedy approval was the early
cooperation of Baltimore District employees, consisting of
chemists, investigators and managers, with officials from Merck's
Elkton, VA manufacturing facility, to create a plan for reviewing
and evaluating manufacturing documentation as soon as it was
available.  The interactions replaced the usual approach of a
single, final, time consuming inspection, and thereby greatly
contributed to the expedited  approval of this promising new
treatment for AIDS. 
      The award consists of a $6.00 hammer, a ribbon, and a card
from Vice President Gore, all in an aluminum frame.
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