2021 LS&HC Horizons - Flipbook - Page 10
FDA inspections and pandemic-related backlog
On March 10, 2020, FDA halted most on-site
inspections due to the COVID-19 pandemic.
As a result, FDA conducted less than half the
number of inspections in FY-20 as it did in
FY-19 (approximately 624 for FY20 versus
approximately 1,523 for FY-19).
FDA’s postponement or cancellation of
inspections due to the pandemic has resulted
in a considerable inspection and drug approval
backlog, and strained the pharmaceutical supply
chain. Many of the inspections postponed or
delayed in FY-20 were pre-approval inspections
(PAIs) (FDA conducted approximately 250 PAIs
in FY-19) for pending applications; many more
were follow-up inspections at facilities referenced
in applications on compliance hold due to such
facilities’ compliance status.
This significant backlog has caught the eye of the
U.S. Government Accountability Office (GAO),
which recently published a report pushing FDA to
address the inspection backlog by, among other
things, using the agency’s alternatives to on-site
inspections. FDA will be under pressure in 2021
and beyond to increase inspections and start
relying more on alternative methods to traditional
Thus, it is unlikely FDA will return to businessas-usual at the end of the pandemic. Rather, we
expect FDA inspection activity to be in overdrive
as the agency uses its records request authority
and newly piloted virtual inspection tools on top
of the agency’s traditional on-site activities to
address the backlog.
FDA’s focus on the pharmaceutical supply
chain will also likely mean enhanced scrutiny
for manufacturers of critical medicines and
manufacturers that are the sole source of
product. This will likely mean more inspections
(on-site and virtual) and more records requests
for manufacturing sites making important
medicines and those that are critical to
supply chain continuity — particularly those
manufacturing sites located outside the U.S. This
is consistent with the CARES Act, which requires
manufacturers to develop and implement
“redundancy risk management plans” to identify
and evaluate supply chain risks for critical drugs.
In the wake of COVID-19, FDA will also
continue to encourage the adoption of advanced
manufacturing technologies, including
continuous manufacturing and Artificial
Intelligence (AI), as a way to strengthen and
ensure continuity of the pharmaceutical
Partner, Washington, D.C.
Senior Associate, Washington, D.C.
Senior Specialist, San Francisco