FDA Guidance for Adverse Event Reporting During COVID-19 Crisis

Adverse event reporting, with which some pharmaceutical and medical device manufacturers require assistance from their marketing research and data analytics departments and partners/vendors, continues during the COVID-19 crisis.

The Food and Drug Administration (FDA) released guidance at the end of March with the agency’s “recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.” The FDA expects that workforces will be “reduced” (both in industry and at FDA) during a pandemic, while adverse events “may increase,” so the agency recommends an approach to reporting that will focus attention on: “reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic”; “other reports indicated in this guidance”; and “reports on products presenting special concerns as specified by FDA.”

FDA’s guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic,” indicates that corporate research departments and their partners/vendors shouldn’t expect to decrease or stop adverse event reporting (if already required) during the coronavirus outbreak, but that administrative collecting and processing may be delayed while resources are preoccupied elsewhere. The responsibility to collect and report (eventually) remains unchanged.

For more on adverse event reporting in the marketing research context, see the Insights Association’s guidelines.

This information is not intended and should not be construed as or substituted for legal advice. It is provided for informational purposes only. It is advisable to consult with private counsel on the precise scope and interpretation of any laws/regulation/legislation and their impact on your particular business.

NewsGovernment AffairsHoward Fienberg, CAE – The Insights Association