FDA Wants Consumers to Report Problems
A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line 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.
"Their initial response was that the reporting form was too technical, and they suggested a more consumer-friendly version," said Beth Fritsch, R.Ph., MBA, deputy director of FDA's Office of Health and Constituent Affairs.
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 (http://www.accessdata.fda.gov/scripts/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.
Even though consumers have been less likely than health care professionals to report problems to MedWatch, their cooperation to date has already been beneficial. For example, consumer reports to MedWatch led 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.
Consumers can play a particularly critical role by reporting unexpected, serious side effects from medicines given to children. Most clinical trials for children's medicines involve a relatively small number of patients, and problems might not be detected until medicines have been used by a large number of children of different ages.
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.
However, consumers who decide to report a problem directly to FDA themselves will find that the new form is now easier and quicker to fill out.
"There is a delicate balance between asking for useful, scientific data and encouraging participation by making the form accessible to consumers," said Fritsch. "We've made a great effort to find that balance."
Consumers are not expected to provide proof that the problem was caused by the particular product. And 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.
Fritsch, who noted that MedWatch is marking its 20th anniversary, concluded: "Every report counts."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
June 3, 2013
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