Source:
Associated PressToday: October 31, 2007 at 13:35:5 PDT
Foreign Drugs Get Little ScrutinyBy ANDREW BRIDGES
Associated Press Writer
WASHINGTON (AP) - Government inspectors visit the
foreign companies that make more and more of the
drugs used in the United States just once every
eight to 12 years on average, according to
congressional investigators.
That's far less oversight than domestic producers face.
Prescription drugs and drug ingredients pour into the
United States from an estimated 3,000 foreign companies,
though the real number is unknown and could be as high
as 6,700, the inspectors said in a memo to members of
the House Energy and Commerce subcommittee on
oversight and investigations The memo was released
Wednesday.
The FDA plans to inspect just 300 of those thousands
of firms this year, announcing in advance its intent
to do so each time. Of those inspections, most are of
plants that make drugs awaiting FDA approval. Just 15
are of the type of periodic assessment meant to ensure
a company's products remain safe in the years following
FDA approval, though some pre-approval inspections also
include some post-approval surveillance.
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