The Guidance issued March 19 revises and replaces FDA’s February 2012 final guidance titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the Guidance applies not just to an influenza pandemic, but to any pandemic, including COVID-19.
The Guidance includes information about pandemic preparedness and reaffirms FDA’s expectations for adverse event reporting during and after a pandemic. FDA expects that firms will maintain normal adverse event reporting processes to the maximum extent possible during a pandemic. However, FDA acknowledges that it does not intend to object if submission of certain required adverse event reports is delayed due to pandemic-related high employee absenteeism.
During a pandemic, industry and FDA workforces may be reduced due to high employee absenteeism, while still obligated to report adverse events related to use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic. This Guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic. FDA believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on the following types of reports:
- Reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic
- Other reports indicated in the Guidance
- Reports on products presenting special concerns as specified by FDA
FDA acknowledges that pandemic preparedness is a global responsibility and that industry should develop continuity of operations plans (COOPs) during a pandemic.
Reporting During a Pandemic
During a pandemic, normal adverse event reporting processes should be maintained to the maximum extent possible. All adverse event data should be handled using a firm’s usual standard operating procedures, and regulatory and statutory requirements for adverse event reporting should be met to the maximum extent possible.
Firms should develop and implement their COOPs to address a potential situation where they are not able to fulfill all adverse event reporting requirements because of pandemic-related high employee absenteeism. FDA recommends that in planning, firms consider the following factors, among others:
- What activities are directly relevant to the processing and submission of mandatory adverse event reports to FDA?
- How would sites based in the United States and abroad be differentially affected by a pandemic?
- What are the relative amounts of resources dedicated to mandatory adverse event reporting at each site?
Firms that are unable to fulfill normal adverse event reporting requirements during a pandemic should maintain documentation of the following conditions:
- Declaration of the pandemic (e.g., by the World Health Organization), including date of declaration of the pandemic and ending date of the pandemic
- High absenteeism and/or other factors (e.g., an increase in adverse event reporting) preventing the firm from meeting normal adverse event reporting requirements
Firms should notify the appropriate FDA units responsible for adverse event reporting compliance when these conditions exist as soon as practicable.
Enforcement Approach During a Pandemic With High Employee Absenteeism
FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism at the same time that reporting of adverse events related to pandemic-related medical products may increase. FDA encourages all firms to plan for these circumstances to maintain the highest feasible level of adverse event monitoring and reporting throughout the pandemic period.
Recognizing that a pandemic may reduce a firm’s capacity to comply with adverse event reporting requirements, FDA does not intend to object if, because of pandemic-related high employee absenteeism, certain required adverse event reports are not submitted to FDA within the time frames required by statute and regulation, provided that any delayed reports are submitted within six months of the restoration of adverse event reporting processes to their pre-pandemic state.
FDA notes that the Guidance does not apply to adverse event reporting during a pandemic by firms that are able to continue reporting operations. FDA strongly encourages all firms to submit as many required reports as possible, in order to minimize reporting burdens once adverse event reporting processes have been restored to the pre-pandemic state.
Reporting After the Pandemic
After the pandemic is resolved and a pre-pandemic state has been restored, it is expected that firms will resume fulfilling all reporting requirements on time as well as submit reports that were not submitted due to pandemic-related high employee absenteeism. Firms are generally expected to submit these reports to FDA within six months of restoration of the adverse event reporting process to the pre-pandemic state.
Firms that cannot meet adverse event reporting requirements at the minimum levels identified in this Guidance should consult the appropriate FDA organizational unit responsible for adverse event reporting compliance.