House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad

06 May 2022

Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal US FDA coordination to prevent quality issues from causing drug shortages.

beacon in a rocky sea — punishing beacons in seas of poor quality • Source: Alamy

An inspections subsection of the draft US House of Representatives user fee reauthorization bill unveiled by Democratic and Republican leadership on 4 May could, if enacted, add a cloud of suspicion to high-quality facilities in troubled pharmaceutical manufacturing regions.

The subsection also would codify expectations for a US Food and Drug Administration pilot program of surprise surveillance inspections abroad.