The document, released yesterday by the US Food and Drug Administration, contains guidance on all aspects of the adverse event reporting system, including minimum data requirements and recordkeeping requirements.
New Adverse Event Reporting (AER) regulations came into effect in December 2007, requiring all manufacturers, packers, distributors or marketers of dietary supplements to notify FDA of any serious adverse event reports received in connection with their products.
The current guidance on using this AER system follows draft guidance issued by FDA in 2007, several months before the regulation became effective. At the time, the supplements industry had submitted comments on the draft guidance. These, it says, have been carefully considered by FDA in its new guidance document, which irons out some of the points that could have been misinterpreted.
To view some of the industry comments submitted at the time, click here.
What, when and how
The new guidance, available here, re-iterates that a serious adverse event is a reaction that resulted in death, hospitalization or the need for medical intervention.
A serious adverse event report must be submitted by the party whose name appears on the product label via FDA’s mandatory MedWatch Form 3500A, available here. (AERs can also be submitted by consumers using the voluntary MedWatch Form 3500).
There is currently no on-line option for submitting AERs, although FDA said it is working on creating one.
Reports must be submitted no later than 15 business days after they are received by the company.
Manufacturers must retain all records related to serious AERs for a period of six years. During an FDA inspection, the agency is authorized to have access to all adverse event report records that manufacturers are required to maintain.
Minimum data elements
FDA identifies the five points below as the minimum data that must be submitted with each AER:
· An identifiable patient
· An identifiable initial reporter
· Identity and contact information for the responsible person (i.e., the manufacturer, packer, or distributor submitting the serious adverse event report to FDA)
· A suspect dietary supplement
· A serious adverse event or fatal outcome
The ‘initial reporter’ is the person who first notifies the company about a serious adverse event. Information on the dietary supplement must include the full product name as well as additional information to “uniquely identify” the product, such as its physical form, flavor or packaging form.
FDA states: “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.”
Other points made in the guidance include:
· If a serious AER involves multiple supplement products manufactured or distributed by the same company, then only one report must be made, which lists all products.
· If a serious AER involves multiple products manufactured or distributed by more than one company, then the firm that receives the report must submit it to FDA, indicating which products are its own and which are those of another manufacturer. Companies are then advised to notify each other of the reports submitted.
· If a serious AER involves a product that has been discontinued, a report must still be submitted to FDA.
Reporting is not admitting
FDA’s guidance also clarifies that submitting a serious AER does not mean that a company is admitting its product is linked to the adverse event.
“Your submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported,” it writes.
AERs are considered “safety reports”, said the agency, which “may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the serious adverse event.”