FDA guidance on adverse event reporting during a pandemic

The US Food and Drug Administration (FDA) have published an updated guidance on post-marketing adverse event reporting for medical products and dietary supplements during a pandemic.

This guidance applies to any pandemic, including the current COVID-19 outbreak. It provides recommendations on how to address the anticipated workforce and resource shortages, coupled with the potential increase in case report workload due to the increased use of medicinal products to fight the virus.

Compliance should be maintained as much as possible, however the FDA accepts that flexibility will be required in adverse event reporting responsibilities to ensure business continuity. If a company is unable to undertake normal adverse event reporting functionality during the pandemic, they should maintain documentation of a pandemic declaration, for example, by the World Health Organisation (WHO). They should also notify the FDA as soon as possible with the factors that are preventing compliance with reporting requirements. The FDA will accept that certain safety reports can be delayed, as long as they are submitted within 6 months of restoration of normal capacity.

The guidance includes a table defining which reports should be submitted and which can be stored if normal processes are not possible. For any products of which there are pre-defined special concerns regarding safety, full compliance and periodic reporting requirements will be expected. For all other products, periodic safety reporting may be postponed. For 15-day Alert reports, the following reports should be submitted within the required timeframe:

  • Reports associated to products approved for an indication related to the pathogen causing the pandemic, including pandemic vaccines
  • Reports associated to products approved within prior three years
  • For biologics only, reports with a fatal outcome

All other reports can be stored and submitted later if necessary.

The guidance also provides information on reporting for other types of products such as medical devices, human cells, tissues and blood products.

It must be noted that this guidance is not intended to discourage adverse event reporting during a pandemic by firms that are able to continue reporting operations.

To view the full guidance, click here.