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|FDA
Has Not Inspected Many Foreign Companies
That Manufacture Medications, Medication
Ingredients Imported to U.S., GAO Report
Finds
Nov 02, 2007]
FDA this year has not visited as many
as two-thirds of foreign companies that
manufacture medications or medications
components imported by the U.S. subject for
inspection, according to a report from the
Government
Accountability Office released on
Thursday during a hearing of the House
Energy and Commerce
Oversight and Investigations Subcommittee.
Under current law, FDA must inspect U.S. companies that
manufacture medications or medications
components at least once every two years,
but no such requirement exists for
inspections of foreign companies, although
an estimated 80% of medication ingredients
and 40% of medications sold in the U.S. are
imported (Bridges,
AP/San
Francisco Chronicle,
11/1).
According to the report, FDA used
information from two databases -- one that
contains 3,000 foreign companies that
manufacture medications or medications
components imported by the U.S. and one that
contains 6,800 -- to compile a list of 3,249
foreign companies subject for inspection
this year.
However, FDA has inspected only 7% of those foreign
companies, the report said (Edney,
CongressDaily, 11/1). The
report said that FDA "could not identify a
previous inspection" for 2,133 of those
foreign companies. In addition, the report
estimated that, at the current rate, FDA
would require 13 years to inspect all of
those companies.
The report also said that FDA officials
could not determine the exact number of
foreign companies overseen by the agency
(Wilde Mathews,
Wall Street
Journal, 11/2). GAO released a
similar report in 1998.
Testimony
At the hearing, Marcia Crosse, director of
health care for GAO, said, "More than nine
years after we issued our last report on
this topic, FDA's effectiveness in managing
the foreign drug inspection program
continues to be hindered by weaknesses in
its data systems" (Bogdanich,
New
York Times, 11/2).
Subcommittee Chair Bart Stupak (D-Mich.)
asked, "How can we have any confidence FDA
is truly managing the risk that may come
from foreign-made drug products if the FDA
doesn't know the exact number or location of
foreign drug manufacturers?" (AP/San
Francisco Chronicle, 11/1).
FDA Commissioner Andrew von Eschenbach said
that the agency has sought to address the
issues. He said, "We recognize that the
world is evolving and our local markets now
provide products largely from a global
marketplace" (New
York Times, 11/2). According
to von Eschenbach, FDA has requested $247
million in fiscal year 2008 for efforts to
improve technology and infrastructure
related to inspections of foreign companies
that manufacture medications or medications
components imported by the U.S.
Carl Nielsen, a former FDA official who
served at the agency for almost 30 years,
said, "The imports have tripled, but the FDA
resources have remained the same" (Walker,
CQ
HealthBeat, 11/1).
CBS'
"Evening
News" on Thursday covered the report.
The segment includes comments from Nielsen;
former FDA Commissioner William Hubbard of
the
Coalition for a Stronger FDA; and von
Eschenbach (Reid, "Evening News," CBS,
11/2). Video of the segment is available
online.
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