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How To Complain About FDA-Regulated Drugs, Devices, and Dietary Supplements

Adverse events outside of research: Strange as it seems, few consumers seem to know how or when to complain to FDA. Consumers (yes, people without medical training …) can report adverse events and problems with medical devices, drugs, dietary supplements, and vaccines.

FDA provides information to consumers who wish to file a report about drugs, medical devices, or dietary supplements through MedWatch at: http://www.fda.gov/medwatch/report/consumer/consumer.htm

You can file a report online, by phone, or by mail.

Online: https://www.accessdata.fda.gov/scripts/medwatch/
If you decide to use the online form it's smart to print out a copy of FDA Form 3500 (below) so you can gather your thoughts.

Telephone: 1-800-FDA-1088

Surface Mail and Fax:
1. Download FDA Form 3500 Voluntary Reporting from http://www.fda.gov/medwatch/SAFETY/3500.pdf.
If you have the full version of Adobe Acrobat, e.g., Adobe Acrobat Professional™ (not the free Adobe Acrobat Reader™), you can fill out and print the Fillable FDA Form 3500 at http://www.fda.gov/medwatch/SAFETY/FDA-3500_fillable.pdf.
2. Read the Instructions for Completing MedWatch Form 3500 at http://www.fda.gov/medwatch/REPORT/CONSUMER/INSTRUCT.HTM.
3. Either mail the completed form to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
4. Or fax the completed form to: 1-800-FDA-0178.

General information on the FDA MedWatch system is available from http://www.fda.gov/medwatch/how.htm.

Reports of adverse of events with vaccines should be reported through the VAERS system at https://secure.vaers.org/VaersDataEntryintro.htm.

Ideally you should take the MedWatch form to your primary care physician or the physician who prescribed the drug or medical device for you and ask her to fill it out and send it to FDA. This may not be possible and FDA realizes this, as they indicate in their instructions for consumers (above). You should ask your physician to fill out the report because she is best able to provide the information FDA needs to evaluate the problem. It's true that you know best what you're experiencing, but not having medical training and experience means you may overlook important signs and symptoms. If your physician refuses to fill out the form or otherwise report your problem, ask why. If or when you don't get an extremely reasonable explanation, simply report the problem yourself.

Don't worry if you can't provide complete information: fill in as much as you can and send it to FDA. A complete form is the exception rather than the rule.

You need not be 100% certain that the drug, device, or dietary supplement caused the problem because this isn't what the reporting system is for. MedWatch is the beginning of the reporting system. FDA evaluates the reports and tries to determine whether or not the adverse event associated with the product was in fact caused by the product. Sometimes this is simple; most often it isn't. Because reports to the MedWatch system need to be evaluated to see if there is a causal relationship, reports can't be used in law suits against manufacturers or otherwise counted, compiled, or held out as evidence that drug, device, or dietary supplement X caused adverse event Y. This means you cannot get anyone in trouble by reporting a problem.

One consequence of unrestricted reporting to MedWatch is that the system can be abused. When consumers are hurt or bewildered by a change in their health which they believe was caused by a device, drug, or dietary supplement, it's natural for them to be angry. Some people, and sadly some organizations, have at times filed exaggerated or inaccurate reports incorrectly supposing the sheer bulk of reports would prompt FDA to remove the offending product from the market or restrict its use and availability. FDA has been evaluating adverse event reports since time began and they're adept at spotting patterns in the data. In fact, the agency expects a certain increase in reports following media coverage of high-profile drug, device, or dietary supplement injury cases. Aside from simply being wrong, submitting inaccurate information diverts scarce agency personnel resources. If you think FDA should remove a product from the market or restrict its use, the most effective way to get the agency to consider your request is by filing a Citizen's Petition. Follow this link for information on How to File a Citizen's Petition with FDA.

If you're curious how scientists sort out whether an adverse event was caused by a drug (or a device) or by chance, this article may be useful:   Nebeker JR, Barach P, Samore MH. Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting. Ann Internal Med. 2004;140:795-801. Available from http://www.annals.org/cgi/reprint/140/10/795.pdf.

Last point: reporting through MedWatch sends your private medical information over a secure server to FDA. The agency is obligated to protect your privacy by keeping the information confidential. If you decide to complain to the manufacturer of a drug, medical device, or dietary supplement in addition to FDA, insist that your information be recorded by a licensed health care professional to maintain your privacy.

Complaints about false, misleading, or deceptive products and sales tactics can be filed with the Federal Trade Commission (FTC) at http://www.ftc.gov/.


Last Updated: 2006-02-16

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