On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.”
At bottom, the FDA recommends that companies should maintain normal adverse event reporting procedures as much possible during a pandemic. However, the guidance recognizes that a pandemic may lead to high levels of employee absenteeism that could delay submission. In such a case, the FDA advises that companies focus their limited resources on the following types of reports:
- reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic;
- reports on products presenting special concerns as specified and communicated by FDA; and
- other reports indicated Table 1 of the FDA guidance.
Where a company is able to report more than this minimum amount, the FDA advises that companies prioritize the order of reports. For example, companies should submit 15-day reports before 30-day reports, and should submit both before periodic safety reports.
In the event that adverse event reporting is delayed during a pandemic, the company should retain documentation of:
- the declaration of the pandemic, including date of declaration of the pandemic and ending date of the pandemic, and
- high absenteeism and/or other factors that prevent the company from meeting normal adverse event reporting requirements.
When business operations return to normal, the FDA expects that companies will submit any adverse event reports stored during the duration of the pandemic. The guidance states that companies should submit all reporting requirements within 6 months of restoration of the adverse event reporting process to its pre-pandemic state. Companies should submit stored reports in order of priority (e.g. 15-day reports first, then 30-day reports, followed by periodic safety reports.)
The guidance also recommends that companies create a continuity of operations plan (COOP) in the event of a pandemic. Such COOP should include instructions for reporting adverse events and provide a plan for the submission of any stored reports at the end of the pandemic. Companies can refer to the HealthCare Emergency Preparedness Information Gateway site, which provides resources for developing a COOP.
More resources on the FDA’s response to COVID-19 are available on its website here. We will continue to monitor for updates from the FDA regarding advice to industry. In the meantime, stay well!
For other helpful information during this pandemic, visit our COVID-19 Resource Center.