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

NOTE TO CORRESPONDENTS         Donald C. McLearn:  301-827-6250
November 3, 1997               
                               Consumer Hotline:   800-532-4440


        FDA-ISPE PARTNERSHIP WINS VICE PRESIDENTIAL AWARD
     
     A partnership of the Food and Drug Administration (FDA) and
the International Society for Pharmaceutical Engineering (ISPE)
that can save industry millions of dollars and benefit consumers
has been selected for the "Hammer Award" from Vice President Al
Gore. The ceremony honoring the FDA-ISPE team took place today,
November 3, as part of ISPE's annual meeting at Marriott's Marco
Island Hotel in Florida.
     The award-winning team of ISPE engineers and FDA's drug and
enforcement experts developed a list of "similar equipment"
needed for efficient implementation of Scale-Up and Post-Approval
Change (SUPAC) guidance for products in immediate release-solid
oral dosage form.
     The guidance and the "Similar Equipment List" provide a
substantive regulatory relief in filing of change information and
manufacturing changes, and thereby provide earlier consumer
access to products and bring significant savings to the industry.
The list, which has been published in the Federal Register, is
now available on FDA's Internet home page (www.fda.gov).
     "This project demonstrates the benefits of cooperation
between government and industry," said Doug Farbrother from the
Vice President's National Performance Review office, who
presented the award. "It reduces red tape, saves FDA's and
manufacturers' resources, and helps hold down the cost of health
care, without lowering the product standards."
     The award was received by Joseph X. Phillips, deputy
director of FDA's Central region, Dr. Roger Williams from FDA's
Center for Drug Evaluation and Research, and Larry Kranking, ISPE
president, on behalf of the FDA specialists and pharmaceutical
engineers who worked together on the project.
     The Hammer Award is given to federal employees and their
private sector partners who have advanced the Vice President's
National Performance Review by cutting red tape, improving
service to customers, and helping build a better and more 
cost-effective government.    
     The award consists of a $6.00 hammer, a ribbon, and a note
of appreciation from Vice President Gore, all set in an aluminum
frame.
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