ATTENTION !!
This post was updated on 20-May-2020 to reflect the changes brought by the revised version of the Guidance Document published by the FDA on 11-May-2020. Resulting revisions are tracked (in Red & Highlighted in Yellow).
The U.S. FDA has published a new Guidance Document on 19-Mar-2020, which is entitled : “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”.
This post was updated on 20-May-2020 to reflect the changes brought by the revised version of the Guidance Document published by the FDA on 11-May-2020. Resulting revisions are tracked (in Red & Highlighted in Yellow).
The U.S. FDA has published a new Guidance Document on 19-Mar-2020, which is entitled : “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”.
This is not
exactly a new document and in reality, this represents a minor revision of the
2012 guidance on “Postmarketing Adverse Event Reporting for Medical Products
and Dietary Supplements During an Influenza Pandemic". The update clarifies
that the guidance is applicable to any pandemic, including the current COVID-19
pandemic and not just an influenza pandemic.
Possible Impact of a Pandemic
This
guidance provides recommendations to address the anticipated workforce shortage
that can result from high absenteeism in the Industry and at the FDA during a
pandemic, while the volume of case reports may increase due to the widespread
use of medical products to face the pandemic.
Although
compliance should be maintained to the maximum extent possible, the guidance
brings flexibility to prioritize AE reporting responsibilities when resources
become insufficient, which should be considered in Business Continuity
arrangements.
Business Continuity and
Prioritization
Companies that
are unable to fulfill normal adverse event reporting requirements during a
pandemic should maintain documentation of the declaration of a pandemic (e.g.
by the WHO), and of the factors that are preventing the firm to comply with its
reporting requirements, i.e. high absenteeism and/or increase in caseload. The
FDA should be notified as soon as possible.
In these
circumstances, the FDA will accept that certain safety reports are not
submitted within the regulatory timeframes provided that delayed reports are
submitted within 6 months of the restoration of AE reporting capabilities to
their pre-pandemic state. However, a different timeframe may be set by the FDA (see
Section D of the Guidance Document).
FDA defines Priorities for
Safety Reports
The
guidance includes a table that defines which reports companies should submit and
which may be stored if necessary. Here is a summary for approved drug and
biological products (NDA, ANDA, or BLA):
- FDA will communicate with firms if there are products and issues that present special concerns, in which case full compliance with expedited and periodic reporting requirements is expected.
- For all other products, Periodic Safety Reporting may be suspended.
- Regarding Expedited Safety Reporting (i.e. 15-day Alert reports), while other reports may be stored if necessary, the following reports should be submitted within required timeframes:
1-
|
Reports associated to products
|
2-
|
Reports associated to products approved within prior three years
|
3-
|
For
|
Besides these rules for approved drug and biological products, the table provides guidance for other types of products, including Prescription drug products marketed without an approved NDA (including compounded or repackaged products), Medical Devices, Blood Products, Human Cells, Tissue, and Cellular and Tissue-Based Products (HCT/P), etc.
_______________________________________
Thierry Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.
Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.
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