MedWatch: Improving on 20 Years of Excellence

By: Margaret A. Hamburg, M.D. 

This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA. 

Margaret Hamburg, M.D.Reports of problems with FDA-regulated products provide information we need to protect consumers.  In the 1950s, FDA was alerted to the fatal blood disorders associated with the antibiotic chloramphenicol as a result of a lone physician’s report. This dramatic illustration of the importance of voluntary reporting prompted our initial efforts to encourage physicians to systematically report adverse medical product reactions. 

MedWatch was launched in 1993 by then-FDA Commissioner David Kessler to expand the voluntary system beyond physicians to include other health professionals such as nurses and pharmacists. 

In a journal article announcing the launch, Dr. Kessler said he hoped the new MedWatch system would encourage health care professionals to regard reporting “as a fundamental professional and public health responsibility.” 

During the past 20 years, MedWatch has prevented serious illnesses and even deaths by alerting FDA to problems. Actions range from removing products from the market to adding warnings of risks on product labels.

During that time, FDA has systematically expanded MedWatch to: 

    • make it easier for providers to report serious events;
    • make it clear to physicians and others what types of reports FDA wants to receive;
    • more widely disseminate information on FDA’s actions that have resulted from adverse event and product problem reporting; and,
    • increase physician understanding and awareness of drug-and device-induced disease.

To continue that tradition, this week FDA’s MedWatch is launching a new, consumer-friendly reporting form with less technical language. Additionally, MedWatch is working with consumer groups to promote more participation in MedWatch. 

Consumers have been encouraged to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993. However, previous efforts to increase participation have been aimed predominately at health care professionals. But the fact that more consumers are turning to the Internet to research health information created an opportunity that MedWatch is seizing. 

FDA is also launching MedWatchLearn, a web-based learning tool designed to educate students, health professionals and consumers on reporting in a way that provides the best information for reviewers to further investigate a problem. 

I urge consumers and health care professionals to submit reports, and encourage the use of the MedWatchLearn to gain a better understanding of preparing a report that is useful to FDA. Your help is invaluable, and enables us to continue ensuring that the products we regulate are safe and effective. 

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration

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