Mandatory Adverse Event Reporting: What You Need to Know

By Rick Kingston, President, Regulatory and Scientific Affairs

Most people are familiar with adverse event monitoring by the Food and Drug Administration (FDA), involving everything from dietary supplements to prescription drugs and medical devices. There are other agencies that require mandatory adverse event reporting, such as the Environmental Protection Agency (EPA) under the 6(a)(2) provision, and the Consumer Product Safety Commission (CPSC) under the Toxic Substance Control Act (TSCA).

Mandatory reporting of adverse events to regulatory authorities requires monitoring and documenting adverse event reports according to requirements set forth by a regulatory body. It is typically required of manufacturers that have received reports of injuries associated with the use of their product. Also, various states impose mandatory adverse event reporting requirements for products sold within their jurisdictions, like for pesticides and medical cannabis.

Common to most, if not all, regulatory reporting, is that the regulatory authority determines specific criteria for adverse event definitions. They also set forth which adverse events need to be reported either on an expedited basis or a periodic basis, and require that all adverse events are documented and available for inspection during regulatory audits. Expedited reports typically involve allegations of “serious” adverse events involving hospitalization, life threatening effects or death. Depending on the class of the product, there may be specific requirements for reporting both serious and unexpected adverse effects.

Misconceptions about Mandatory Reporting

When it comes to regulatory reporting, one of the most common misconceptions we encounter at SafetyCall is when manufacturers don’t believe their product caused an adverse event, and therefore don’t think it needs to be reported. That is simply not the case. Whether or not an adverse event needs to be reported is based on the reporter’s allegation that using the product resulted in an adverse event. In other words, if the reported adverse effects (taken at face value) meet reporting criteria, it has to be documented and/or reported.

Fortunately, and especially for spontaneously reported events that come directly from consumers, regulatory agencies understand not all adverse events are created equal in terms of plausibility or causation. For manufacturer-reported adverse events, specific statutory language acknowledges that such reports are not an admission by the manufacturer that the product actually caused the adverse event.

For more information about whether or not your products meet requirements for reporting of adverse events, contact SafetyCall.