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Adverse Event Reports - Considerations

View PDF of the Adverse Event Reports Section (72 KB)


Background

Summary of Public Comments

Transparency Report Arrow Considerations

View All Adverse Event Reports Draft Proposals   


Considerations
In general, comments from individuals requested disclosure of more information about adverse events that are reported in connection with FDA-regulated products, including information about the type of event, the number of adverse events reported, and/or frequency of occurrence.  Comments noted that the information should be provided to the public in an accessible, user-friendly format, and in a timely fashion.  One comment urged the FDA to make adverse event reporting systems “straightforward to use” and to make information about adverse events “as easily retrievable as possible.”

The Task Force considered the public’s interest in FDA providing adverse event information as soon as practicable, and even when the Agency has not determined whether the adverse event is likely associated with product.  The Task Force considered the risk that the public may draw assumptions and possibly conclusions about a product based on incomplete information.  The Task Force also considered that it is important for FDA to be transparent about the limited usefulness of adverse event reports that are disclosed when FDA has not analyzed their association to the FDA-regulated product.  The Task Force considered whether, if preliminary information from adverse event reports is disclosed, a disclaimer should be included that cautions the public about drawing conclusions about products based solely on adverse event information because there is no certainty that the reported event was actually caused by the product and reports do not always contain enough detail to fully evaluate an event.  

The Task Force also took into account the fact that although certain entities (generally manufacturers, packers, distributors and in some cases user facilities) are required to submit adverse event reports, other persons, including, in most cases, health care providers and patients, report adverse events voluntarily.  Thus, there is no way of knowing the actual number of adverse events that may be associated with a product because of under-reporting.  FDA also does not know the actual number of people or animals that have been exposed to a product because sales data and other available proprietary product distribution information, the best estimates available to FDA, do not necessarily equate to product use.  The Task Force considered whether it would be misleading to disclose the frequency of adverse events reported as a percentage of total adverse events reported for a product or as a percentage of the exposed population.  FDA does not receive information about all adverse events and may not have accurate data about the number of people or animals that are exposed to the product, which is necessary to calculate accurately the frequency of adverse events for an exposed population. 

The Task Force considered the Agency’s current capability to quickly process adverse event reports for disclosure to the public.  Regardless of any system used, adverse event reports (i.e., individual case safety reports (ICSRs)) must be reviewed for quality control purposes, entered into the system, and non-public information such as personal information redacted (e.g., name of the patient, or any other information that would identify the patient) before the ICSR describing the adverse event can be disclosed to the public.