Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act ("the Act") has required certain manufacturers, packers, and distributors to report certain adverse events associated with the use of dietary supplements to FDA. As with any new legislative development, the Act has raised numerous questions for those subject to its requirements. Knowing exactly what must be reported and how it is to be reported has presented challenges for the industry. FDA has recently attempted to answer some of the industry's questions with a new guidance document: "Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act" (the "Q&A Guidance").
To trigger a reporting requirement under the Act, an event must be both "adverse" and "serious." For dietary supplements an "adverse event" is simply defined as any health-related event associated with the use of a dietary supplement that is adverse. An adverse event is "serious," and therefore reportable, if it results in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or requires medical or surgical intervention to prevent any of these events.
In addition to having to understand exactly what types of adverse events have to reported, companies also have to comply with detailed rules on the timing, content, and substance of the submitted reports, as well as recordkeeping requirements. FDA issued the Q&A Guidance in an effort to address some of those issues and clarify industry concerns. Specifically, the Q&A Guidance discusses: (1) the minimum data elements for serious adverse reports; (2) how to submit an adverse event report for a dietary supplement; and (3) record maintenance clarification.
Some of the significant parts of the guidance are covered briefly below.
Minimum Data Elements. FDA requires that all serious adverse event reports contain at least the following information: (1) identifiable patient, (2) identifiable initial reporter, (3) identity and contact information for the responsible person, (4) the suspect dietary supplement, and (5) the serious adverse event/fatal outcome. These data elements are deemed necessary in order for FDA to avoid duplication in the records database and determine the appropriate course of action.
What Should Be Submitted with the Serious Adverse Event Report. In addition to submitting MedWatch Form 3500A, your serious adverse event report should also include a copy of the label or outer container of the dietary supplement that is suspected of causing the outcome. If it is not possible to obtain the exact dietary supplement label in question, you should submit a label that is identical to the dietary supplement at issue. In addition, if possible, the serious adverse event report should also contain: (1) hospital discharge summaries, (2) autopsy reports, (3) relevant laboratory data, and (4) other critical clinical data.
How to Submit MedWatch Form 3500A. The MedWatch Form 3500A should be mailed to FDA, along with all relevant attachments. At this time, FDA does not accept serious adverse event reports electronically or via facsimile.
Record Maintenance for Serious and Non-Serious Adverse Events. The Q&A Guidance states that you should keep all records related to serious and non-serious adverse events for six years. This includes copies of the actual report with attachments, new medical information, and all communications with FDA and persons who provided information for the report. These records may be kept in electronic form, as long as you also comply with FDA's electronic record requirements. You should also keep in mind that FDA is authorized to have access to all adverse event report records that you are required to maintain. This means that the records should be organized and readily accessible in case of an FDA inspection.
Understanding your obligations under FDA's adverse event reporting rules is not only critical to ensure that your company is compliant, but, perhaps even more importantly, it is critical to ensure that the FDA has the information that it needs to protect the public health.
The full text of the guidance can be accessed here.