FDA Criticized for Foreign Inspection Problems
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Yesterday a House panel reprimanded the FDA for their poor
performance when inspecting foreign-made medications, in the aftermath of the
recall of contaminated batches of the blood thinner heparin. Increased concerns
over foreign made medicines have been on the rise as Americans have become more
concerned about foreign, particularly Chinese-made, products all around. Last
year consumers saw millions of Chinese-made toys recalled for violations of
lead paint standards among other defects, contaminated Chinese-made pet foods,
and now contaminated heparin has been linked to 81 deaths in the US alone.
Last year the FDA conducted only 30 inspections of the more
than 3,200 foreign drug facilities. The FDA had never inspected the plant where
the suspected heparin contamination occurred. Resources say that the agency
plans on stepping up their inspections this year to total 50. This is simply an
unacceptable in my opinion. We are talking about the health and safety of drugs
taken by millions of American citizens with virtually no federal safeguards to
ensure their safety.
FDA commissioner Andrew von Eschenbach agreed that more
inspections are needed and requested more money for these inspections, but did
not elaborate to what extent the inspections would be expanded. The FDA has
made plans to establish three Chinese based offices to keep a closer eye on the
Chinese manufacturing. The agency is also considering future plans for offices
in India, the Middle East, Latin America, and Europe.
“Last year, this nation’s regulatory failures resulted in
dead dogs and cats,” said Representative Bart Stupak, Democrat of Michigan.
“This year, it has tragically led to the deaths of people. If we don’t make
some rapid progress on fixing the foreign drug inspection program, the next
melamine or heparin tragedy will soon be upon us.”
In order to solve these types of problems the severely under
funded agency is going to need Congress to put their money where their mouth
is. Experts estimate that for the FDA to inspect all foreign facilities at the
same rate as domestic facilities, the current $10 million foreign inspection
budget would need to be increased by seven fold. Without the funds to perform
the inspections the agency has no chance at drastically improving performance
in this area.