FDA Hopes MedWatch Overhaul Increases Consumer Reporting

Federal health regulators are pushing for more consumers to report adverse events associated with medications or medical devices, indicating that it will provide better insight into potential problems or side effects that surface after products are introduced and on the market.  

The FDA announced changes to their MedWatch adverse event program this week, introducing a new consumer-friendly submission form that is designed to be less technical and easier to complete. The agency hopes that these changes will inspire more participation in the program.

MedWatch is a database of adverse event reports submitted by consumers, health care professionals and drug and medical device manufacturers. It allows the FDA and other investigators to spot trends that could indicate a certain drug or medical device has a problem.

Observers often note that only about 1% to 10% of all adverse events are actually reported to MedWatch, meaning that there is a good chance that any problem noticed by the program is greatly underrepresented.

Consumer adverse event reports have led to a number of recalls and more stringent warning labels on products in recent years after issues were revealed that may pose a threat to patient and consumer health, the FDA claims. The FDA is asking consumer groups to promote MedWatch to help increase participation.

“Their initial response was that the reporting form was too technical,” said Beth Fritsch, deputy director of the FDA Office of Health and Constituent Affairs, “and they suggested a more consumer-friendly version.”

In addition to the new form, the FDA launched MedWatchLearn, a new web-based tool for teaching students in medical, nursing and pharmaceutical programs to fill out MedWatch reports.

Consumers who experience an adverse event that they believe is connected to the use of a drug, food, dietary supplement, or medical device can report directly to the FDA by filling out the new form. They can also ask their health care provider to submit a report or report the problem to the manufacturer. While manufacturers are required by law to turn over those reports to the FDA, there have been some incidents where they failed to do so, however.