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May 21

USA FDA Guidance for Adverse Event Reporting during a Pandemic – What effect on the EU?

The United States Food and Drug Administration (FDA) have released their final guidance and recommendations document, to assist in providing industry and supporting organisations, involved with the reporting of post-marketing adverse reactions, with an insight into how they can best fulfil their reporting requirements and, more specifically, the reporting of ICSRs during the COVID-19 pandemic.

In summary of their guidance, the FDA have acknowledged that a large number of companies will be directly impacted by the pandemic, with emphasis placed on the detrimental impact witnessed to resources, workforce absenteeism and timely case submissions and, as a result, released this document to promote the continuation of ICSR reporting through enabling those organisations to better allocate these previously mentioned resources and prioritise their reporting.

Furthermore, within the guidance document, the FDA have communicated that they have already identified the products which companies should focus their reporting efforts on, during the pandemic, in addition to the products which have potential safety issues causing additional patient risks and serious unexpected cases.

Moreover, when regarding products not identified as such by the FDA and for companies unable to fulfil their reporting requirements, the FDA has provided further information on the process and timescales involved for how to maintain a level of compliancy.

In this regard, the FDA have communicated that these companies should maintain all documentation which evidences the declaration of the pandemic and proof of high absenteeism during this time period, in addition to ensuring the correct responsible authority are notified and all delayed reports are successfully submitted within 6 months of returning to a pre-pandemic state.

However, the FDA also emphasised that this guidance does not apply to those firms who can fulfil their reporting responsibilities during the pandemic and, in this regard, have provided all appropriate timescales and prioritisations within their guidance document, in addition to urging any and all individuals/organisations, who have concerns with their meeting of these recommendations, to contact their appropriate responsible authority immediately.

Finally, it was communicated that the FDA is currently revising their 2012 guidance document titled ‘Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic’, to ensure that this guidance, and any future guidance, is best applicable to any and all pandemics.

PharSafer will continue to monitor this situation for further updates and will relay any information as and when it is made available.

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PharSafer Comment

It is clear that the FDA are adopting a pragmatic view of the situation as a result of the current pandemic. The effects of any late reporting have to be documented as clearly, due to the pandemic and no other issues associated with resignations or a general lack of resources.

The FDA have provided their timelines for reporting post pandemic, expecting any backlog to be cleared within 6 months.

Regarding prioritisation, the FDA have also stated that ICSRs should be prioritised above periodic reports for submission. Again, these should be completed within 6 months of the end of the pandemic.

What is unclear is how the late cases will be identified within the FAERs database, with differentiating as being late as a direct result of the pandemic, rather than simple late reporting. PS would recommend making a note of any such cases internally, with QA approving and monitoring these late submissions for discussion in any subsequent FDA inspection.

The problem comes however if these reports need onward reporting to the EU because there is no contingency for any delays in reporting in the EU. Also, the EU does not allow late submissions of periodic reports, indeed in the EU late provision of a Periodic Report (PBRER) in the EU would result in an electronic refusal to accept the report.

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