Revised Serious Adverse Event Reporting During COVID-19 Pandemic

Hello,

I hope this finds all of you and all of your family well. As your trusted FDA regulatory partner, EAS Consulting Group strives to keep your company informed of current activities at the Agency that may impact your business. Given the Coronavirus Disease 2019 (COVID-19) outbreak, the FDA has been working hard to fulfill its responsibility of protecting the public health and ensuring the safety of our nation’s food supply.

In accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, dietary supplement manufacturers, packers, or distributors must submit all complaints with the accusation of a Serious Adverse Event (SAE) to the FDA via the electronic MedWatch Form 3500A available on the FDA website within 15 business days of receipt of the complaint.

However, given the COVID-19 outbreak today the FDA issued a new Guidance for Industry, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, that replaces the 2012 Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic to update and clarify that the guidance applies to all pandemics.

The guidance discusses the FDA’s intended approach to enforcement of SAE reporting requirements for medical products and dietary supplements during a pandemic, acknowledging that both industry and FDA workforces may be reduced because of high employee absenteeism and other limited resources. During this pandemic, as much compliance and continuity with company complaint processes and SAE reporting requirements should be maintained as possible, with those related to product safety taking highest priority. However, if necessary SAEs can be “stored” and reported to the FDA within the six (6) months after the restoration of normal activities. It is important that the declaration of the pandemic issued by the World Health Organization (March 11th, 2020 for COVID-19) and the situation of high absenteeism or other factors that is/are preventing normal SAE requirements be well documented.

After the pandemic is resolved and a pre-pandemic state has been restored, it is expected that firms will resume fulfilling all reporting requirements on time as well as submit reports that were stored because of pandemic-related high employee absenteeism.

Please let me know if EAS Consulting Group can be of any assistance during this time.

Take Care,

Tara Couch

Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com

Posted in COVID-19.