A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the U.S.
FDA’s guidance describes the minimum data elements for AERs, along with how, when and where to submit a report. It also includes information on records maintenance and access for serious and non-serious adverse event reports and related documents.
AERs “received through the address or phone number on the label of a dietary supplement, as well as all follow-up reports of new medical information received by the responsible person within one year after the initial report, must be submitted to FDA no later than 15 business days after the report is received,” according to FDA’s guidance.
FDA recommends that all other serious adverse event reports received by the responsible person also be submitted to FDA within 15 business days of receipt.
“Prompt submission of serious adverse event reports is important for public health reasons,” FDA states. “…Without prompt notification of all serious adverse events associated with dietary supplements, FDA would be unable to investigate and follow up promptly, which in turn could cause delays in alerting the public when safety problems are found. Therefore, the agency recommends that all serious adverse event reports received by the responsible person should be reported to FDA within 15 business days of receipt, regardless of the means by which the responsible person received the initial report.”
As soon as all of the minimum data elements (i.e., identifiable patient, initial reporter, identity and contact information of responsible person, suspect dietary supplement and serious adverse event) are known to the responsible person, the 15-business-day time clock begins to run. That date is Day 0 and should be entered in section G, block 4, on FDA Form 3500A.
If the responsible person does not initially receive sufficient data for a serious adverse event report to FDA, but later receives additional information completing the minimum data elements listed in Question 13, then the responsible person should submit the serious adverse event report within 15 business days of the date the additional information was received, with that date entered in section G, block 4, of FDA Form 3500A.
The manufacturer, packer, or distributor of a dietary supplement must use a MedWatch form when submitting a serious adverse event report to FDA. The statute permits but does not require FDA to modify the MedWatch form for dietary supplement reporting. The agency has determined that MedWatch Form 3500A, the form used for mandatory reporting of adverse events for other FDA-regulated products, is also the most appropriate MedWatch form currently available for mandatory reporting of dietary supplement adverse events.
“As FDA gains experience with mandatory adverse event reports for dietary supplements, the agency will consider whether the form should be modified to facilitate dietary supplement reporting,” the agency said. Instructions for filling out MedWatch Form 3500A are included in the Appendix of the agency’s guidance.
The following five data elements should be included in any serious adverse event report for a dietary supplement: an identifiable patient (Section A); an identifiable initial reporter (Section E); identity and contact information for the responsible person (i.e., the manufacturer, packer or distributor submitting the serious adverse event report to FDA) (Section G); a suspect dietary supplement (Section C); and a serious adverse event or fatal outcome (Section B).
The responsible person should actively seek information on any minimum data elements that are not initially provided by the reporter and wait to submit a serious adverse event report to FDA until the information is obtained. FDA does not intend to take enforcement action for failure to report a serious adverse event where, after diligent efforts, the responsible person is unable to obtain all of the five minimum data elements.
FDA recommends that the responsible person document its efforts to obtain the basic elements for a serious adverse event report. As discussed below in the questions and answers about recordkeeping, the responsible person must keep records related to any adverse event report it receives for six years, regardless of whether the event must be reported to FDA.
As part of the serious adverse event report, FDA also encourages the responsible person to attach the following, as appropriate: (1) hospital discharge summaries, (2) autopsy reports, (3) relevant laboratory data, and (4) other critical clinical data.