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Mar 21
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FDA Guidance – ADR reporting during COVID-19 pandemic

In response to the current COVID-19 pandemic, the FDA has just provided guidance and recommendations on how to best perform post-marketing drug safety operations and, more specifically, the act of reporting adverse reactions during a pandemic.

The guidance covers medicines, devices, advanced therapies; dietary supplements; non-prescription medications and blood products.

The following summary highlights the 5 key topics within the FDA’s guidance document: Pandemic Preparedness; Business Continuity; FDA Expectations; FDA Action and Post-Pandemic Procedures.

Pandemic Preparedness

  • Highly anticipated that workforces will become significantly reduced, due to high employee absenteeism.
  • Increased demand and usage of medicinal products, either as a direct or indirect result of the COVID-19 pandemic.
  • Companies should reflect on their current adverse event reporting functions, for both U.S and international locations, and refer to external planning resources to aid business continuity during the pandemic.

Business Continuity

  • Businesses should now be preparing and implementing their business continuation plans, with supplementary material available on the Department of Health and Human Services (HHS) website.

FDA Expectations

  • All efforts should be made to ensure the proper reporting of adverse reactions is upheld to the standard that is required to comply with the regulations.
  • In the event that standards cannot be met and reporting process begin to become impacted by factors caused by the pandemic, companies should be prepared to action their continuity of operations plan (COOP).
  • Should a company require their COOP become ineffective, a record of evidence should be formulated; consisting of a declaration of pandemic, records of associated factors, such as high absenteeism, and notification of this sent to all appropriate authorities if necessary.

FDA Action

  • There is no intention from the FDA to sanction companies if the matter of high employee absenteeism results in certain reports not being submitted within their required timeframes.
  • Specific guidance has been given, regarding which reports firms may ‘store if necessary’ as a result of pandemic-related high employee absenteeism (see guidance for details).
  • However, this guidance only applies to companies unable to meet their reporting requirements and does not extend to those able to continue reporting operations; nor exempt those companies already not meeting regulatory reporting requirements.
  • Those companies who find themselves in the position of being capable of reporting more than the minimum requirements, but less than regulatory requirements, have been advised to prioritise their submission accordingly and the guidance provides examples of which reports to prioritise for reporting to the FDA ahead of other types of reports.
  • In the event that the FDA has specifically outlined a product as possessing distinct concern, all reporting companies have been instructed to submit all required adverse event reports as an essential priority.

Reporting After the Pandemic

  • Any defaulted reports and reports that have been ‘stored if necessary’ are to be submitted within the 6-month period that follows the restoration of processes; matching the regulatory standards from the pre-pandemic climate.
  • Companies should continue to prioritise the submission of these reports accordingly.
  • In the event that a company is still unable to fulfil their reporting obligations, then the appropriate authority should be contacted immediately.

In addition to the released guidance, The FDA are currently revising their existing guidance produced in 2012, regarding the influenza pandemic for post-marketing adverse event reporting, to ensure that this guidance is relevant to the current COVID-19 pandemic and any future pandemic that follows.


For any further information, directly from the FDA, click here.


PharSafer Comment

The requirement to perform a risk assessment of potential situations that may impact the performance of the pharmacovigilance system is covered under EU legislation within Modules I – IV but without the same focus on just a pandemic situation and certainly without a specific document to explain the requirements during and post the pandemic.

PharSafer have already looked at key areas of pharmacovigilance activities to understand in a pandemic/epidemic situation what the key risk areas are, in order to look at means of obviating the effects of such situations and implementing solutions to remain regulatory compliant. Our innovative approaches are designed specifically to keep our clients compliant.

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