By Suzan Onel and Vanessa Fulton
On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”). The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements.
To summarize, FDA states in the Guidance that adverse event reporting mandated by statute and/or regulation should continue to the maximum extent possible. However, because it anticipates that during a pandemic industry and FDA workforces may be reduced, FDA does not intend to object if, because of pandemic-related high employee absenteeism, certain required adverse event reports are not submitted to the FDA within the timeframes required by statute and regulation, provided that any delayed (“stored”) reports are submitted within 6 months of the restoration of adverse event reporting processes to their pre- pandemic state.
We provide a brief summary of this Guidance below.
- FDA intends to apply its enforcement
discretion during a pandemic and will allow companies to prioritize the
reporting of adverse events related to medical products indicated for the
treatment or prevention of the pathogen causing the pandemic, reports related
to new product safety issues, and reports involving fatal outcomes.
- FDA encourages all firms to develop a continuity of operations plan (COOP) to ensure that a firm’s operations continue during all phases of a pandemic. The COOP should include instructions for reporting adverse events and provide a plan for the submission of any stored reports not submitted within the regulatory timeframes.
- If a firm is unable to fulfill normal adverse
reporting requirements during a pandemic, the firm should:
- implement their COOP,
- maintain documentation of the declaration of a pandemic by the World Health Organization (including the declaration date and ending date),
- maintain documentation regarding any high employee absenteeism, and
- maintain documentation regarding any other factors (such as an increase in adverse event reporting) that prevent the firm from meeting normal adverse event reporting requirements.
- FDA states that the following types of products/applications
and associated reports can be stored and submission can be delayed if normal
processes of mandatory adverse event reporting are not feasible because of high
- Prescription drug products marketed without an NDA – all products with 15-day alert reports;
- Approved NDAs, ANDAs, and BLAs – certain products with 15-day alert reports (see Table 1 of Guidance);
- Approved NDAs, ANDAs, and BLAs – all products with periodic (non 15-day) adverse drug experience reports;
- Nonprescription OTC drugs- Serious Adverse Event Reports (SAER);
- Dietary supplement- SAERs; and
- Device- Medical Device Reports (MDR) for non-fatal
- Details regarding which reports must still be
submitted and which reports firms may “store” are included in Table 1 of the Guidance.
- Firms must submit any delayed reports within six months of the restoration of adverse event reporting processes to their pre-pandemic state.
- FDA may designate some products or issues as
presenting special concerns.
- For these products or issues, FDA expects compliance with normal reporting requirements.
- FDA will communicate with firms to identify any products or issues that present special concerns.
FDA underscores in the Guidance that its intent is not to discourage adverse event reporting during a pandemic by companies that are able to continue to do so. Notably, the Guidance does not address monitoring and reporting of adverse events that might be imposed as a condition for medical products authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) or monitoring and reporting of adverse events as required by regulations establishing the conditions for investigational use of drugs, biologics, and devices. (See 21 CFR parts 312 and 812.)
Please let us know if you have any questions or would like to discuss further.