FDA issued guidance to industry regarding postmarketing adverse event reporting during a pandemic in light of the anticipated lessening of the FDA and industry workforce. During a pandemic, normal adverse event reporting processes should be maintained to the maximum extent possible. Firms should develop and prepare to implement their continuity of operations plan (COOP) in the event they are not able to fulfill all adverse event reporting requirements because of pandemic-related high employee absenteeism. FDA does not intend to object if, because of pandemic-related high employee absenteeism, certain required adverse event reports are not submitted to the FDA within the timeframes 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.

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. 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:

This guidance is not intended to discourage adverse event reporting during a pandemic by firms that are able to continue reporting operations. In addition, this guidance does not address monitoring and reporting of adverse events that might be imposed as a condition for medical products authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3).4 This guidance also does not address monitoring and reporting of adverse events as required by regulations establishing the conditions for investigational use of drugs, biologics, and devices. (See 21 CFR parts 312 and 812.) FDA is revising the final guidance for industry entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic" (2012 final guidance) to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic. This action is necessary to address the Coronavirus Disease 2019 (COVID-19) pandemic and to ensure that the Agency’s recommendations in the 2012 final guidance apply to any pandemic, including COVID-19. Accordingly, this guidance replaces the 2012 final guidance.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Background

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

Pandemic preparedness is a global responsibility. It is expected that widespread human outbreaks of a pandemic, whether overseas or in the United States, will affect industry’s normal functions.

Although overseas outbreaks may not seem to directly affect domestic operations, international medical product and dietary supplement production, availability, and adverse event reporting may be disrupted if a firm’s international sites are affected. Thus, industry should develop plans to ensure continuity of operations during a pandemic (discussed in section III.B). It is important that firms consider the adverse event reporting functions of their U.S. locations and their international locations in the face of a potential pandemic.

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