Reporting Medical Problems to FDA

Have you ever come across a problem with medications or certain products regulated by the FDA and you thought, “Someone should know about this!”? If so, there is a way that you can become involved, something you can do about it. You can file a report with the FDA.

How?

The MedWatch program at the FDA is for anyone, from consumers to medical professionals. The mandate is to accept reports and complaints, investigate them, and advise the public of any problems or issues that result from the investigation.

MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

If, for some reason, you’re not comfortable or able to have your doctor fill out forms, you are more than welcome to do so on your own:

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself. You will receive an acknowledgement from FDA after we receive your report. You will be personally contacted only if we need additional information.

You can read more at the MedWatch site.

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