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Serious Adverse Event Reports: Some More Basics

Article-Serious Adverse Event Reports: Some More Basics

Dean Cirotta, COO and president of EAS Consulting Group, finishes what Kathleen Dunn started. The rest is up to you.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act was enacted on December 22, 2006 and required dietary supplement companies to begin reporting Serious Adverse Events (SAEs) to the FDA on December 22, 2007. Since then the FDA has posted a website for industry on “Dietary Supplements Reporting an Adverse Event at a Glance” and issued a Guidance document, “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.”

In addition, in 2014 the FDA added dietary supplements to the Safety Reporting Portal (SRP,, which allows dietary supplement companies to electronically report SAEs in accordance with the Act).

It is important remember that every company or individual that sells a dietary supplement, with their name on the label, is required to report all serious adverse events to the FDA no later than 15 business days after the report is received. To promote the reporting of SAEs, the FDA requires that every dietary supplement label must include the company’s contact information (the domestic address or phone number).

It is also vital to understand how the FDA defines an adverse event versus a serious adverse event. An adverse event is “any health-related event associated with the use of a dietary supplement that is adverse”, while a serious adverse event is an adverse event that results in:

--A life-threatening experience
--Inpatient hospitalization
--A persistent or significant disability or incapacity
--A congenital anomaly or birth defect; or
--Requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above

Each company must therefore assess each reported adverse event and determine if it must be reported to the FDA as an SAE. Each company should have a responsible and qualified individual to manage adverse and serious adverse events in order to determine if the company has received the minimum information to report an SAE and if an event was actually life-threatening, caused a significant incapacity or required preventive medical intervention, as this is not always clear and obvious. The minimum information required to report an SAE includes:

--An identifiable patient (Section A)
--An identifiable initial reporter (Section E)
--Identity and contact information for the responsible person (Section G)
--A suspect dietary supplement (Section C)
--Aserious adverse event or fatal outcome (Section B)

It is the responsibility of the qualified person to actively and diligently try to obtain the required information so that the SAE can be filed with the FDA.

Many companies also still do not understand that all SAEs must be reported to the FDA regardless of whether or not a causal link can be made to the product in question. The FDA has made this very clear in their guidance documents that “Submitting a serious adverse event report will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported, or that any person included in the report caused or contributed to the event.”

Finally, companies must understand that, during an inspection, the FDA is permitted to review all adverse event report records and SAE filings and that they must retain this documentation for a period of 6 years, regardless of whether the event was reported to the FDA.

Given the criticality of these requirements and the complexities of the process, dietary supplement companies should have a detailed SOP that describes the adverse event intake and management process and SAE reporting requirements and procedure. In addition, they need to have a trained and qualified person to manage this entire process. Without a thorough procedure, formal process and a qualified individual, dietary supplement firms cannot address adverse and serious adverse events in a compliant and effective manner.

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