In response to rapidly changing conditions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) published a revised guidance on postmarket adverse event reporting requirements. The revised guidance applies to drugs, biologics, medical devices, combination products and dietary supplements.
The revised guidance addresses the following areas:
Information on Pandemic Preparedness: The guidance directs manufacturers to the Department of Health and Human Services Pandemic Preparedness Resources website for frequently updated information on the pandemic.
Development of a Continuity of Operations Plan in the Case of a Pandemic: The guidance notes that general information on pandemic preparedness planning can be found on the HealthCare Emergency Preparedness Information Gateway website. That site includes resources for developing a continuity of operations plan (“COOP”), which should include instructions for adverse event reporting and a submission plan for any stored reports that are not submitted in the expected regulatory timeframes.
FDA Expectations for Adverse Event Reporting During a Pandemic: Normal adverse event reporting processes should be maintained to the extent possible. Companies that are not able to fully comply with normal adverse event reporting due to the pandemic should develop and prepare to implement a COOP. In addition, companies should maintain documentation of the high employee absenteeism and/or other factors that are preventing them from meeting normal reporting requirements. The revised guidance does not apply to certain reports, including those for products with special concerns, and reports with regulatory timeframes of 30 days or less.
Reporting After the Pandemic: Companies will resume fulfilling all adverse event reporting requirements on time when the pre-pandemic state has been restored, and will submit stored reports that were collected during the pandemic. The guidance indicates that companies are expected to submit stored adverse event reports to the FDA within 6 months of the restoration of the adverse event reporting process to the pre-pandemic state. In addition, companies should prioritize the order of submission for stored reports by, for example, submitting reports with specified timeframes before submitting periodic safety reports.
The guidance instructs companies that cannot meet even these revised adverse event reporting requirements due to the pandemic should consult with the FDA about how to proceed.
The FDA acknowledges that companies may be impacted by workforce reductions due to high employee absenteeism during the pandemic, and that adverse event reporting may increase for medical products used to respond to the pandemic. The FDA also notes that the “guidance is not intended to discourage adverse event reporting during [the] pandemic” by companies that are able to continue operations.