The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere with the ability of a firm to meet its adverse drug event (ADE) reporting requirements and responsibilities.
Clearly, the FDA expects that, if firms do have enough staffing to meet the requirements, then it expects the normal level of reporting to continue. However, if that is not the case, the Agency expects firms to prioritize reporting based on the seriousness of the ADE (e.g., 15 and 30-day reports should be submitted before periodic reports).
The guidance further indicates:
“FDA intends to communicate with firms if there are products and issues that present special concerns and for which the Agency, therefore, expects compliance with normal reporting as required by statute and regulation during the pandemic. Special concerns could include:
- product-related safety issues such as (but not limited to) newly emerging safety issues (e.g., an antihypertensive drug associated with liver failure or a non-pandemic-related vaccine associated with anaphylaxis)
- product problems with associated adverse events (e.g., non-fatal serious infections associated with a pre-filled syringe that was recalled due to bacterial contamination).”
The FDA’s expectations are that within six months after the restoration of the pre-pandemic ADE reporting state, stored periodic ADE reports should be submitted.
Table 1 of the guidance provides additional detail on FDA expectations from industry. The Agency expects that if firms are not able to comply with the reporting requirements at the minimum as outlined in the table, they should notify the appropriate organizational unit that would have responsibility of review of the ADEs and reports. The full guidance can be found here. Remember that Table 1 of the guidance outlines all of the types of products, including biologics drug products approved or unapproved, OTC products and dietary supplements, medical devices and tissue, and cell and plasma products. Please read this guidance to assure that you have an understanding of the special requirements under these stressful times and are able to stay in compliance with ADE reporting requirements and regulatory expectations.