The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to the postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.
General Approach to Adverse Event Reporting
The document is intended to assist industry representatives in maintaining compliance with applicable requirements on postmarketing adverse event reporting. The scope of the document covers drugs, biologics, medical devices, combination products, and dietary supplements.
According to the position of the Agency, further spreading of the infection leads to the situation when:
- Both the authority and industry representatives may face a certain reduction in the number of the employees available, and
- The significant increase in the use of medical devices resulting in the appropriate increase in the number of adverse events to be reported.
Under the conditions described hereabove, the FDA guidance finds necessary for industry representatives to focus their attention on certain reports, namely:
- Reports regarding the devices intended to treat or prevent the pathogen causing the disease,
- Reports regarding the devices determined by the Agency as ones presenting special concerns, and
- Other reports listed in the document.
At the same time, the Agency explicitly indicates that the companies that reasonably have the possibility to maintain normal operations and reporting procedures should keep reporting as prescribed by the general adverse event reporting requirements. It is also important to mention that the reports related to the investigational use of medical devices, as well as the products authorized for emergency use actually fall outside the scope of the present guidance.
The present guidance constitutes a revision of the guidance “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” issued by the Agency earlier in 2012. Thus, the new document actually replaces the previous one, as being fitted to the particular situation related to the outbreak of the coronavirus disease (COVID-19) caused by the virus “SARS-COV-2” or the “novel coronavirus”.
Adverse Reporting During a Pandemic
First of all, the Agency reminds that each company shall develop a continuity of operations plan (COOP) containing the measures taken to ensure the normal operations of the company during the pandemic. With regard to the adverse event reporting, the appropriate instructions should be included in the COOP together with the plan for the submission of reports that have not been submitted to the authority within the timeframes set forth for such reports.
The Agency expects industry representatives to maintain adverse event reporting process in accordance with the general requirements to the maximum extent possible due to the current situation. In particular, all data related to adverse event reports should be submitted to the regulating authority as prescribed by applicable regulations, and all appropriate requirements should be met.
In case if the company fails to sustain its normal operations due to the high employee absenteeism caused by the disease, the company should act in accordance with its COOP. To be able to deal with such situations, the FDA guidance recommends companies to take into considerations the most important factors including but not limited to:
- The scope of activities related to the reporting,
- The way the pandemic impacts the sites based both abroad and in the US,
- The approximate resources involved in reporting at each of the sites.
The confirmation of the fact that the company is unable to maintain its normal reporting operations should be based on:
- The Declaration of a pandemic issued by the appropriate healthcare authority (including the particular date a pandemic has been declared),
- The description of the particular factors faced by the company preventing it from maintaining the normal reporting operations, such as a significant increase in the number of adverse events to be reported and/or the high absenteeism of the employees caused by the pandemic-related factors.
In case if the company faces the issues described hereabove, it should duly notify the regulating authority and its units responsible for reporting in particular about such issues. At the same time, such notification could be delayed in case if there are more urgent safety issues that need to be addressed.
Recommendations on Adverse Event Reporting
The Agency recommends the industry representatives to take into consideration the possibility of high absenteeism of the employees when developing a plan of operations during the disease.
The authority provides general guidelines regarding the possible ways the companies could deal with such issues since the authority recognizes that these issues could impact significantly the capacity of the company to maintain its reporting activity compliant with applicable requirements.
The authority also states that it would not object if some of the adverse event reports normally required in accordance with the applicable regulation would be submitted with the delay, in case if such delay results from the impact of pandemic-related factors. Thus, the reports explicitly determined by the authority could be stored instead of submitting them within the appropriate timeframe, and the companies are allowed to collect and keep information on adverse events for future submissions. At the same time, the Agency emphasizes that all delayed reports should be properly submitted within 6 months after the normal adverse event reporting process will be restored. The companies are also required to document all the information on adverse events and keep records regarding all the information stored.
The authority also states that the companies should prioritize the reporting process in accordance with the priorities determined by the authority for each type of report. The appropriate information is provided by the authority in the table accompanying the guidance.
According to the general rule, the companies should attempt to submit as many reports, as it is reasonably possible due to the particular situation the company faces. Using this approach, the companies would also reduce the reporting burden they will face later when the normal operations would be restored.
The Agency pays special attention to certain products and issues, for which it expects to receive the reports in accordance with the applicable requirements despite any pandemic-related impact. The list of such issues includes:
- The safety issues related to particular products,
- The adverse events associated with the particular problems of the product.
In such cases, the companies shall maintain the reporting process compliant with the requirements provided by applicable regulations, and these requirements could not be waived.
In a case, if due to the impact of the disease-related factors, the company fails to maintain event the minimum level of reporting requirements described in the guidance, the company should additionally consult with the appropriate units of the FDA responsible for processing adverse events reports to agree on the solutions to be applied.
The FDA guidance expects the companies to restore the normal reporting process after the outbreak of the disease would cease to exist. Then the companies would have to submit all stored and delayed reports in accordance with the priorities, providing that the reports with short timeframes should be submitted to the authority before other reports (e.g. periodic safety reports).
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