Imports act to outsource inspections
The bill would create a user fee on imported food and drug shipments, with the funds generated used to hire additional personnel to perform inspections at the US border and abroad as well as at FDA labs to increase analysis of food and drug imports.
Meanwhile, the FDA said in October that it is considering outsourcing some of its foreign inspections.
Without hinting what changes the agency might seek in its overhaul plan due in November, assistant commissioner for policy Jeffrey Shuren acknowledged that a third-party inspection program might be proposed.
If it does, it will be acting consistently with advice given to Congress by former FDA regulatory counsel and Office of Criminal Investigations special agent Benjamin England.
He testified that the agency “can do a far better job in picking up data that come to it from multiple different sources, including domestic inspections of imported products, foreign inspections, third parties.”
England said there are already many international third-party inspection companies that could help the FDA, such as Bureau Veritas, ITS and Intertech.
They should be factored into FDA's surveillance, backed up to be “a meaningful auditing process,” he said.