LS&HC Horizons 2022 - Flipbook - Page 68
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
68
United States
More FDA inspections are coming soon
FDA is facing pressure to reduce the backlog of pharmaceutical
manufacturing inspections, especially foreign inspections, caused by
the suspension of routine inspections during the Covid-19 emergency.
Although FDA still has persistent vacancies among those who
specialize in foreign inspections, FDA is expected to resume foreign
surveillance inspections as soon as this spring for establishments in
locations identified as Level 1 or 2 Covid-19 travel risk. In addition,
FDA plans to implement pilot programs for foreign drug inspections
in India and China, including using unannounced inspections
and independent translation services. On 2 February 2022, FDA
announced that domestic surveillance inspections are now also
expected to resume.
In a recently released report from FDA’s Office of Pharmaceutical
Quality (OPQ), FDA reported that such tools were applied in support
of site evaluations for 269 product applications in 2021, which
reduced the need for preapproval inspections by 52%. We anticipate
that FDA will continue to use these alternative tools, to some degree,
even after the on-site preapproval inspection frequency increases.
However, so far, FDA has not been willing to use these tools as an
alternative to an on-site inspection for firms that have never been
inspected before or are potentially subject to compliance action based
on a prior inspection, including sites that are the subject of Warning
Letters or Import Alerts.
During the period when FDA was not conducting routine inspections,
the agency relied more on certain alternative inspection tools,
including the following:
• I nformation from foreign regulators obtained through Mutual
Recognition Agreements;
• I nformation from foreign regulatory counterparts obtained through
confidentiality agreements;
• I nformation requested from the facility in lieu or in advance of an
inspection; and
• Remote Interactive Evaluations (RIEs), which use livestreamed video
of operations, as well as remote, live interactions with operators.
David Horowitz
Partner, Washington, D.C.
Lowell Zeta
Partner, Washington, D.C.
Christopher Middendorf
Director of Regulatory Affairs
Washington, D.C.
