In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products during pandemics, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (the Guidance).
Key Takeaways
- When experiencing personnel shortages or increased AEs that prevent meeting standard regulatory AE reporting timeframes, certain reports may be stored and later submitted.
- Firms able to continue reporting operations should continue to meet statutory/regulatory AE reporting deadlines.
- If doing delayed reporting, firms must maintain certain records and communicate delayed reporting to FDA. We recommend validating that the existing systems can handle additional records storage.
- Firms should not only consider domestic but also international site reporting capacity.
- Firms should have Continuity of Operations Plans that address AE reporting.
Reporting Timeframes
FDA’s Guidance provides firms a way to prioritize AE reporting, describing which reports must be submitted within standard regulatory timeframes and which may be stored:
- Drug Products
- 15-day AE and follow up reports, and five-day reports submitted to applicants by non-applicants:
- Reports for approved New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products for the pandemic pathogen or products approved within the last three years—Submit within standard timeframes
- Reports for other NDA and ANDA products—Store, if necessary
- NDA/ANDA quarterly/annual AE reports—Store, if necessary
- 15-day and follow up reports for prescription products marketed without an approved NDA—Store, if necessary
- 15-day serious AE reports for nonprescription drugs marketed without an approved application (e.g., over-the-counter monograph drugs, nonprescription grandfathered/DESI drugs)—Store, if necessary
- Biologics (Approved Biologic License Applications)
- 15-day AE and follow up reports, and five-day reports submitted to applicants by non-applicants:
- Pandemic vaccine products and products approved within the last three years—Submit within standard timeframes
- All other biologics—Submit death reports within standard timeframes; store other reports, if necessary
- Quarterly/annual AE reports—Store, if necessary
- Medical Devices
- Five-day Medical Device Reports (MDRs)—Submit within standard timeframes
- 30-day manufacturer/importer MDRs and 10-day user facility MDRs—Submit deaths within standard timeframes; otherwise, store, if necessary
- Dietary Supplements
- 15-day serious AE reports—Store, if necessary
- Other Product Categories
- Blood collection and transfusion fatality reports for blood and blood components—Submit within standard timeframes
Source plasma donor fatality reports—Submit within standard timeframes
Human Cells, Tissue, and Cellular and Tissue-based Products (HCT/P) reports—Submit within standard timeframes
- All Product Categories
- Products identified by FDA as presenting special concerns—Submit within standard timeframes.
Importantly, delayed reporting only applies to firms that are unable to meet their reporting obligations due to high employee absenteeism or increased AEs reporting. Firms, however, should strive to maintain standard reporting and, even if full reporting cannot be accomplished, FDA encourages firms to report as much as possible.
Firms opting to store reports must document the following:
- The pandemic declaration (including the declaration date and the pandemic end date). (We recommend documenting international declarations, such as from the World Health Organization, as well as US declarations)
- High absenteeism or other factors that prevent meeting normal reporting timeframes (Note firms where employees are working from home may not qualify for delayed reporting, absent other circumstances, as the Guidance does not address displaced, rather than absent personnel)
- What records have been stored
- The date reporting processes are restored
Firms should also notify the appropriate FDA unit responsible for AE reporting compliance of the need for delayed reporting as soon as possible. Stored reports must be submitted to FDA within six months of restoration of AE reporting processes.
Firms should ensure that received reports are evaluated to ensure that there are no safety signals warranting standard reporting and/or remedial action.
Firms with Emergency Use Authorizations (EUAs) may also have separate reporting obligations under the EUA.
Continuity of Operations Plans
FDA recommends that firms have a Continuity of Operations Plan (COOP) that includes plans for AE reporting. COOPs should address the processing and submission of reports, how domestic and international sites may be impacted, and dedicated AE reporting resources.
Law clerk Angela M. Silva provided helpful contributions to this article.
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Contacts
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact please contact any of the following Morgan Lewis lawyers:
Washington, DC
Kathleen Sanzo
Jacqueline Berman
Michele Buenafe
Dennis Gucciardo