Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic

In the Guidance[1], FDA understands that because of the COVID-19 pandemic, industry and FDA workforces may be reduced because of high employee absenteeism and that this could affect the mandatory reporting of adverse events within the timeframes required by the regulations. Because of this, the Agency is delaying the timeframes in certain instances, and those instances are set forth below.

First, however, FDA states that each regulated company should develop a Continuity of Operations Plan (a COOP) to ensure that the company’s operations can continue during the various stages of a pandemic.[2] If a company is able to continue its reporting obligations then the Guidance does not apply. However, if a company is unable to fulfill its normal adverse event reporting requirements, then it should maintain documentation of the following:

1. The declaration of the pandemic (e.g., by the World Health Organization), including the date of declaration and the ending date, and
2. An explanation of the high absenteeism and/or other factors (e.g., an increase in adverse event reporting) that is/are preventing the company from meeting normal adverse event reporting requirements.

If these two conditions are documented in a company’s files, then FDA says that it will exercise its enforcement discretion in not enforcing certain of the timeframes required by the statutes and regulations, provided that any delayed reports are submitted within 6 months of the restoration of adverse event reporting processes to their pre-pandemic state. The reports that are affected are the following:

Approved NDAs and ANDAs

1. If labeled for a pathogen causing the pandemic, reports are due at the normal times.
2. If the NDA/ANDA was approved in the prior three years, reports are due at the normal times.
3. All other postmarketing safety reports can be delayed and stored as necessary.
4. All periodic reports can be delayed and stored as necessary.

Approved BLAs

1. Pandemic vaccine reports are due at the normal times.
2. For biologics (vaccines or nonvaccines) approved in the prior three years, reports are due at the normal times.
3. Postmarketing Safety Reports for all other biologics can be delayed and stored as necessary.
4. All Periodic Reports can be delayed and stored as necessary.

Prescription and Nonprescription Drug Products Marketed without an NDA or ANDA

Postmarketing Safety Reports can be delayed and stored as necessary.

Dietary Supplements

Postmarketing Safety Reports can be delayed and stored as necessary.

Blood and Blood Components/Source Plasma/Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P)

Postmarketing Safety Reports are due at the normal times.

Medical Devices

1. 5-Day MDR Reports are due at the normal times.
2. 30-Day MDR Alert Reports from both manufacturers and importers that involve a patient death are due at the normal times.
3. 30-Day MDR Alert Reports from both manufacturers and importers that involve a nonfatal serious injury or device malfunction can be delayed and stored as necessary.
4. 10-Day User Facility Reports to a manufacturer that involve a patient death are due at the normal times.
5. 10-Day User Facility Reports to a manufacturer that involve a non-fatal injury may be delayed and stored as necessary.

[1] The Guidance, entitled Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic. While this Guidance is published because of the COVID-19 pandemic, FDA is saying that it will apply to any pandemic that occurs in the future.

[2]FDA specifically refers in the Guidance to pandemic preparedness planning as set forth at the HealthCare Emergency Preparedness Information Gateway website.