FDA Inspections Will Suffer Under FDA Cuts: Lawyers
The recent FDA layoffs are raising red flags across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approvals and challenge companies’ ability to maintain compliance with federal regulations. HHS laid off about 3,500 full-time FDA employees earlier this month, impacting key support roles that enable inspection logistics, including travel planning and translation services. While FDA inspectors were protected in the staff purge, the absence of crucial inspection support staff is expected to strain the agency’s ability to conduct timely and thorough facility inspections.
Pre-approval inspections are likely to suffer from staff shortages, according to a Morgan Lewis legal update. With staffing reductions, remaining FDA personnel may face the dual burden of investigative and administrative duties, increasing the likelihood of bottlenecks, the attorneys wrote. In some cases, the agency may revert to remote, paper-based inspections, reminiscent of measures taken during the Covid-19 pandemic. These virtual assessments, while necessary under current constraints, are often less effective and can lead to delays in communication and potential misunderstandings, they said.
“These delays may be exacerbated if a facility does not pass a PAI [pre-approval inspection] the first time, resulting in the issuance of a 483 inspection report, a Complete Response Letter, and the need for a second, likely delayed inspection,” according to the update. “It is therefore critical for applicants and their contractors to confirm that facilities and laboratories are inspection-ready, including through conducting mock inspections and vigorous vendor selection and control processes. Companies that heavily rely on contract manufacturing organizations (CMOs) for chemistry, manufacturing, control, and analytical activities should carefully select, partner with, and audit experienced contractors to ensure a comprehensive assessment of inspection readiness.”
Additionally, the update said that manufacturers should stay ahead of potential issues by strengthening internal quality systems, increasing inspection readiness, and closely monitoring contract manufacturing organizations. Best practices include routine and risk-based audits, clear contractual quality expectations, and real-time tracking of performance indicators. For companies navigating past enforcement actions, it stated that timely closure of open issues is critical — especially in the context of mergers or acquisitions, where unresolved regulatory concerns could affect valuation. If a reinspection is delayed, firms may benefit from third-party regulatory audits to verify compliance readiness.