APR Nov/Dec 2022 - 52

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MANUFACTURING
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FDA's Updated Inspectional Approach in the
Post-Pandemic Landscape
Arif S. Noorani, Partner and
Priyanka Amirneni, Associate
Food, Drug and Medical Device Compliance and Enforcement, Sidley Austin LLP
Introduction
The COVID-19 pandemic posed unprecedented challenges to the U.S.
Food and Drug Administration's (FDA) inspection program. Emergency
public health measures, including global travel restrictions and
lockdowns, forced FDA to essentially suspend its inspection activities,
creating a significant inspections backlog.1
Both the pharmaceutical
industry and Congress voiced concerns over the backlog and the
potential ramifications for the American public. In response, FDA
piloted new inspection techniques and strengthened its reliance on
mutual recognition of inspections by international regulatory bodies.2
Based on the relative success of these initiatives during the pandemic,
FDA is now adopting them beyond the COVID-19 pandemic as
" modernized approaches to protecting public health. " 3
FDA's Inspectional Authority
To protect consumers in the United States, FDA closely regulates
pharmaceutical manufacturing, and in order to do so, the agency
has broad statutory authority to physically inspect any factory,
warehouse, or establishment in which drugs are manufactured,
processed, packed, or held for introduction into U.S. commerce.4
This authority allows the agency to inspect " all things, " including
" records, files, papers, processes, controls and facilities " 5
bearing on
an establishment's compliance with current Good Manufacturing
Practice (cGMP).6
The authority to inspect in person extends not
only to manufacturers located in the U.S., but to any site around the
world that either manufactures drugs to the U.S. market or seeks
approval to do so.7
Among other things, onsite inspections permit
FDA investigators to tour the facilities and laboratories to observe the
day-to-day operating environment, conduct comprehensive reviews
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of manufacturing and quality records such as deviations and changes
from the approved process, and directly interview factory employees
regarding their cGMP compliance. The FDA investigators who perform
the inspections are subject matter experts in a range of relevant areas
(e.g., chemistry, microbiology, engineering, aseptic practices), and are
specifically trained to identify manufacturing or quality deficiencies
that can become serious problems if not corrected. As a result, FDA
heavily relies upon its inspections to ensure that U.S. marketed drugs
are safe and effective.
Inspections During the Pandemic
Although FDA has seen a general decline in domestic and foreign
inspections since 2016 due to staffing vacancies,8
the unprecedented
obstacles posed by COVID-19 and the related public health measures
triggered an extremely sharp drop in inspections.9
Limitations on
in-person contact due to the COVID-19 virus such as lockdowns and
travel bans created substantial obstacles for investigators to continue
inspecting facilities in person.10
In March 2020, FDA announced it
would temporarily halt foreign and domestic inspections other than
those it deemed " mission critical. " 11
Following this announcement,
FDA only conducted three foreign inspections for the rest of the
fiscal year, compared to hundreds more during the same time
period in each of the prior two years.12
This is especially noteworthy
given that approximately 70 percent of facilities which manufacture
active pharmaceutical ingredients and more than 50 percent of
facilities which manufacture finished drugs for the U.S. market are
located outside the U.S.13
FDA's domestic inspections also decreased
significantly.14
And the decline in inspections continued through Fiscal
Year 2021, creating a substantial backlog of thousands of inspections,15
raising concerns from both public and private entities.16
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