Earlier this month, the Food and Drug Administration (FDA) celebrated the
20th anniversary
of its
MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form that will encourage more consumer participation.
Under MedWatch, health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated products. Reporting to FDA such “adverse events” as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new safety information forward and help the FDA take appropriate actions, including:
- Making necessary changes on the label for a medication to better describe how the product should be used;
- Influencing how a patient receiving the product should be monitored; and,
- Issuing product recalls, warnings, corrections, or safety messages which FDA issues through MedWatch.
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. Consumers had been able 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.
Because the healthcare professional form was too complicated, FDA worked with groups such as AARP, Consumers Union, and the National Women’s Health Network to develop a new Consumer Form–Form FDA 3500B. To spread awareness of the reporting mechanism, FDA is using social media, including Twitter, email lists and electronic newsletters—interestingly, FDA is using such platforms without having issued its final guidance on how manufacturers can use such platforms to advertise and educate consumers about reporting adverse events as well.
FDA is also getting help in this effort from librarians, consumer organizations, patient advocacy groups, health professional organizations and schools of medicine, pharmacy and nursing. FDA Commissioner Margaret Hamburg also announced the new form of FDA’s Voice Blog.
FDA also introduced a new web-based learning tool, called MedWatchLearn. This tool is designed to educate students, health care professionals and consumers on how to properly complete a report. MedWatchLearn also provides examples of a quality report that includes critical information to help FDA evaluate the event or product quality complaint. In announcing these new materials, FDA issued a consumer alert explaining how and when to use the new consumer reporting form.
Consumer reports are important, FDA recognized. They helped lead to a nationwide recall of a particular lot of pre-filled syringes. Consumer reports also alerted FDA to an unusual issue: Men using a testosterone gel on their upper arms and shoulders were inadvertently exposing, and harming, children. The reports led to stronger product warning labels to alert the public and urge that the gel be covered after application so it wouldn’t get on other people.
“MedWatch is one of the lines of defense against products that are contaminated or that pose risks that weren’t previously known,” said Anna Fine, Pharm.D., director of FDA’s Health Professional Liaison Program. “Greater consumer involvement will mean we have more eyes and ears available to catch problems before they escalate.”
MedWatch reports sometimes provide the first clue that an issue needs investigation and possible action. In other cases, a clinician or researcher inside or outside FDA might first suspect a link between a problem and a drug or other product, and MedWatch becomes a useful database that FDA experts can search for additional clues.
How to Report
Consumers can continue to ask their health care professional to file a MedWatch report or to report a suspected problem directly to a drug manufacturer. By law, companies are required to report to FDA certain serious problems that may have been caused by their products, including in cases where consumers report suspected problems to the company. Currently, the vast majority of more than 900,000 MedWatch reports a year are funneled to FDA through companies.
Consumers are not expected to provide proof that the problem was caused by the particular product. Fritsch adds that consumers should send the report even if they don’t have all the information requested. Questions are answered at MedWatch’s toll-free line, 1-800-332-1088, between 8 a.m. and 4:30 p.m. ET.
MedWatch forms for both consumers and health care professionals must be faxed or mailed. Online submission capability will be available in coming months. According to the Form FDA 3500B, FDA states that consumers should use the form when:
- You were hurt or had a bad side effect (including new or worsening symptoms) after taking a drug or using a medical device or product.
- You used a drug, product, or medical device incorrectly which could have or led to unsafe use.
- You noticed a problem with the quality of the drug, product, or medical device.
- You had problems with how a drug worked after switching from one maker to another maker.
FDA said not to use the forms for vaccines or investigational drugs or medical devices (those being studied, not yet approved) – report problems to your doctor or to the contact person listed in the clinical trial. The form can be used for reporting problems with
- drugs, including prescription or over-the-counter medicines, and biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments, and bone) and gene therapies
- Medical devices, including any health-related kit, test, tool, or piece of equipment (such as breast implants, pacemakers, diabetes glucose-test kits, hearing aids, breast pumps, and many others)
- Nutrition products, including vitamins and minerals, herbal remedies, infant formulas, and medical foods, such as those labeled for people with a specific disease or condition
- Cosmetics or make-up products
- Foods (including beverages and ingredients added to foods)