The Food and Drug Administration (FDA) is celebrating the 20th anniversary of its MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form intended to encourage more consumer participation.
Under MedWatch, health care professionals and consumers submit reports to the FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. Over the years, most of the voluntary MedWatch forms have been submitted by health care professionals, but recently consumers have been increasingly interested in participating in the program. The new, consumer-friendly MedWatch reporting form is a response to consumer concerns that the form is too technical. FDA officials worked with groups such as AARP, Consumers Union, and the National Women’s Health Network in developing the new form. Also being introduced is a new Web-based learning tool, called MedWatchLearn, which is designed to educate students, health care professionals, and consumers on how to complete a report properly. MedWatchLearn also provides examples of quality reports that include critical information to help FDA evaluate the event or product-quality complaint.