NEWS
06/03/1993

<TITLE>FDA Announces Program to Improve Drug, Biologics, Medical Device Safety</TITLE>
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P93-21                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Mike Kubic (301) 443-3285

    The Food and Drug Administration today announced a program to improve the
safety of drugs, biologics, medical devices, dietary supplements, medical
foods, infant formulas and other regulated products by encouraging health
professionals to report serious adverse events and product defects. 
    The new program -- called MEDWatch -- is a comprehensive approach to
FDA's post-marketing surveillance and is aimed at more involvement by health
professionals and a better focus of their reporting. 
    Clinical trials that precede product approval typically include safety
data on several hundred or several thousand patients.  Once on the market, the
much wider use of the drug or medical device occasionally brings out
additional data on the safety and efficacy of the product that can have a
bearing on its use. The purpose of MEDWatch is to bring this information to
FDA's attention as soon as it is gathered by health professionals.      
    "MEDWatch is not just a new FDA system; it is a way of making reporting
of adverse events and product problems a part of the culture of health care
providers," said FDA Commissioner David A. Kessler, M.D. "Physicians, nurses
and others who care for patients are the first to know when a drug or
medical device does not
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                                       Page 2, P93-21, MEDWatch
perform as it should.  The sooner they report it to FDA, the faster the
agency can analyze the problem and take corrective action."
    The American Medical Association, Pharmaceutical Manufacturers
Association, Public Citizen Health Research Group and more than 50 other
organizations representing health professionals have agreed to promote the
program to their members by special mailings, ads and other means. 
    As part of MEDWatch, the agency has developed several ways to make it
easier for health professionals to report adverse events involving almost
all regulated products. Concerns with vaccines will continue to be reported
separately through the Vaccine Adverse Events Reporting System.
     An important part of MEDWatch is a simplified reporting form that
replaces five other forms previously issued for the same products. 
    The self-addressed, one-page form, which can be folded and mailed
postage-free, will be made widely available in several publications,
including the Physicians' Desk Reference, the FDA Medical Bulletin and AMA
Drug Evaluations. 
    In addition, the agency has established for adverse event information a
special 24-hour, 7-day-a-week toll-free telephone line. Health professionals
will also be able to make their reports electronically by computer.
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                                        Page 3, P93-21, MEDWatch
    FDA keeps track of the performance of drugs, biologics and medical
devices on the basis of mandatory reports -- from manufacturers and device
distributors and user facilities -- and voluntary reporting by health care
professionals. 
    FDA has repeatedly identified side effects that did not emerge during the
clinical trials of drugs. Adverse drug reaction reports led to the recall of
such drugs as suprofen, which in 1986 was found to cause flank pain
syndrome, and temafloxacin, which last year was linked to hemolytic anemia
in some patients. 
    Two years ago, FDA discovered a potentially fatal latex sensitivity that
prompted an alert to health professionals. In 1992, voluntary reports by
health professionals about product quality problems resulted in 52 drug
recalls. In addition, manufacturers voluntarily accepted many FDA
recommendations for corrective actions to improve the quality of their
products.  
    However, in a typical year fewer than one-third of all adverse drug
reaction reports and fewer than one-half of medical device problems reported
to FDA involve serious patient outcomes. Moreover, a survey has indicated
that as many as 50 percent of physicians are not aware of FDA's adverse
events reporting system. 
    MEDWatch is designed to stimulate voluntary reporting by all health care
professionals, and to focus them on adverse events that represent a serious
health hazard. 
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                                       Page 4, P93-21, MEDWatch
    To encourage maximum participation in the program, the agency will hold
next year a special conference on medication- and 
device-induced problems for academics and practitioners. FDA will also make
a sustained effort to keep health professionals informed about the use of
their MEDWatch reports, and it will encourage medical, pharmacy, dental and
nursing schools to include in their curricula lectures on adverse event and
product problem recognition and reporting. 
    Adverse events that should be reported include the patient's death,
life-threatening illness or injury, hospitalization, disability, congenital
anomaly and experiences that required intervention to prevent permanent
impairment of health. MEDWatch also needs to be informed about suspected
contamination, questionable stability, defective components and poor
packaging or labeling of regulated products.
    FDA is one of the eight Public Health Service agencies in HHS.
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