Friday, June 7, 2013

MedWatch, Part of the FDA, Needs You

The FDA, the agency that protects consumers by regulating food, drugs, medical devices, and cosmetic products has been around since the beginning of the last century. The FDA was created by the 1906 Pure Foods and Drug Act that was championed by Harvey Washington Wiley, the chief chemist at the Bureau of Chemistry, then part of the U.S. Department of Agriculture.

It was recognized that the country needed an organization that would protect US citizens from people who deliberately mislabeled products or who sold medicines, products, or machines that clearly could not do what was claimed. Healthcare professionals voluntarily reported when they found issues among FDA-approved products, but it was only 20 years ago in 1993, with the implementation of MedWatch that the FDA made it easier for professionals to report possible problems with medications or devices. Consumers were also welcome to make reports and they did. However, while there has been an increase in consumer-reported problems, there were concerns that the reporting process was too complicated and this could discourage reports that could be valuable.

Consumer reports are of particular interest because they may notice things that healthcare professionals may not. For example, according to an FDA press release:

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."

Making it easier

As MedWatch marks its 20th year of helping people make reports to the FDA, it has launched a new consumer-friendly form that they hope will make it simpler for members of the general public.

The form answers questions such as when you should fill one out, what types of products are covered by MedWatch, how to fill it out, and how you can have further contact with the FDA if you need. There is also a video that explains the reporting process.

Have you ever made a report about an unsafe product or a previously unknown adverse/side effect?

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