Wanted: Consumers to Report Problems to FDA's MedWatch

Wanted: Consumers to Report Problems to FDA's MedWatch
February 13, 2014

A new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) online system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

The less technical form is part of a larger effort to encourage consumers to submit quality reports.

By reporting your experience or suspicion of a product problem to MedWatch, you could help identify an unknown risk and potentially spark a variety of actions—from changes to a warning label to removal of the product from the market.

Consumers have been welcome to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993, although the focus had always been more on encouraging reporting from health care professionals.

But as more and more consumers visit online sites to research their conditions and understand their care, opportunities for increasing their participation in MedWatch became clear. FDA asked consumer groups to help promote the website and the MedWatch reporting form to their members.

Working with groups such as AARP, Consumers Union and the National Partnership for Women and Families, FDA created a new form and published it for public comment in the Federal Register. Those comments were also considered, further revisions were made, and the less technical form is now available at MedWatch.

To spread awareness of the reporting mechanism, FDA is using social media, including Twitter, email lists and electronic newsletters. It is also getting help in this effort from librarians, consumer organizations, patient advocacy groups, health professional organizations and schools of medicine, pharmacy and nursing.

Additionally, MedWatchLearn, a new web-based learning tool, will be used to teach students in medical, pharmacy and nursing schools to fill out MedWatch reports and encourage others to do so.