FDA Issues Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

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FDA Issues Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic 

The U.S. Food and Drug Administration has issued a final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including the current COVID-19 pandemic. 

During a pandemic, FDA expects that widespread human illness will affect industry’s normal functions, including adverse event reporting, and manufacturers should develop continuity of operations plans.  More specifically, industry and FDA workforces may be smaller because of high employee absenteeism.  Meanwhile, reporting of adverse events may be higher because of the widespread use of medical products indicated to treat or prevent the pathogen causing the pandemic.

 

With this understanding, this guidance discusses FDA’s intended approach to enforcing adverse event reporting requirements for medical products and dietary supplements during a pandemic.  FDA believes this approach will make it possible for firms to focus their limited resources on specific adverse event reports, including those reports focused on medical products related to the pandemic.

For instance, the guidance explains that FDA does not intend to object if, because of pandemic-related high employee absenteeism, firms do not submit certain required adverse event reports to the agency within the timeframes required by statute and regulation, provided that firms submit any delayed reports within six months of restoring the adverse event reporting processes to their pre-pandemic state. More information about the type of adverse events reports for which a delay in filing may be appropriate is included within the guidance.

After the pandemic is resolved and a pre-pandemic state has been restored, FDA expects that firms will resume fulfilling all reporting requirements on time as well as submit reports that were stored instead of submitted during the pandemic. 

FDA is revising the 2012 final guidance for industry entitled , “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic,” to clarify that the guidance is applicable to any pandemic, not only an influenza pandemic.