Guidance on Adverse Event Reporting (AER)

Guidance on Adverse Event Reporting (AER)

Considerations and MedWatch Worksheet for receiving AERs associated with dietary supplements - Log in to download

Published: Thursday, September 1, 2011

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (the Act) was signed into law on December 22, 2006. This law placed new responsibilities on certain companies that sell dietary supplements and nonprescription (i.e., over-the-counter) drugs to receive adverse events associated with their products when used in the United States, and to submit to the Food and Drug Administration (FDA) any such reports that meet the law’s definition of “serious.” These new obligations went into effect on December 22, 2007, and FDA published Guidance for Industry in June 2009 (the June 2009 guidance) to describe the minimum data elements that should be included in serious adverse event reports associated with dietary supplements submitted to FDA.

The present document was prepared to assist companies that receive adverse event reports (AERs) and are responsible for submitting serious adverse event reports (SAERs) under the Act to obtain complete and accurate information about such reports. The information provided here addresses internal policies that may be established by companies that market such products in preparation for receiving an adverse event report, and also presents ideas for communicating with the reporter of such an event.

The Act dictates that SAERs must be submitted to FDA on a MedWatch form, and also authorizes (but does not require) FDA to modify the existing form for this new use. This document is therefore also focused on the specific information fields that are included on the current form used for mandatory reports, MedWatch Form 3500A, and provides information to assist in providing the minimum data elements in any submitted report, as described in the June 2009 guidance. If FDA modifies the current MedWatch form or the guidance, AHPA will promptly revise this document as needed.

This document also includes a report of a meeting with FDA staff attended by AHPA and other industry groups in December 2009 to discuss FDA’s process for evaluating AERs when they are received. It may be useful for any company that submits an SAER to FDA to adopt a similar evaluation process so that FDA’s conclusions can be predicted to some degree.

This document was prepared with a focus on dietary supplement products and marketers of these products. It may also have direct relevance for marketers of nonprescription drugs. Readers of this document should also review the June 2009 guidance, or the similar July 2009 guidance published in relation to questions and answers regarding the Act as it affects nonprescription drugs.

While AHPA believes that all of the information here is accurate, any company that chooses to use this information is advised to discuss all aspects related to this subject matter with a qualified consultant, an attorney or with relevant FDA staff.


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