Imports act to outsource inspections

Share this article:
Reps. John Dingell (D-MI), Frank Pallone (D-NJ) and Bart Stupak (D-MI), have introduced the "Food and Drug Import Safety Act of 2007" (HR 3610), which they say will dramatically improve the nation's system for ensuring the safety of imported food and drugs.

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.

Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Headliner: Proteus CEO takes an original path

Headliner: Proteus CEO takes an original path

Andrew Thompson, CEO, Proteus Digital Health

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...