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13 yrs for FDA to inspect foreign drug plants |
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Written by Stumo
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Thursday, 14 February 2008 |
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Poisonous heparin
is the latest Chinese product to harm our citizens. 350 people
became ill from the heparin, which is a common blood thinner injected
into our bodies by our doctors in our hospitals.
The article also mentions a GAO report I missed. The report had these happy facts:
The Government Accountability Office recently reported that at its
current inspection pace, the F.D.A. would need at least 13 years to
inspect every foreign drug plant that exports products to the United
States. The office, an independent arm of Congress, also found that the
F.D.A.s computer systems were deficient and it had little idea how
many plants had been approved for exports to the United States.
Wow.
UPDATE: The FDA violated its own rules by approving the plant to sell heparin without inspecting that plant. "It was obviously a glitch," said the FDA. No. Its a big freaking deal.
Dr. Ajay Singh, director of dialysis at the Brigham and Womens
Hospital in Boston, said he was astonished by what he called the many
failures to ensure a safe supply of heparin. There are 450,000 people
in the United States on dialysis, and nearly all of them need copious
doses of heparin, he said. Heparin is also used in cardiac surgery and
among chronic care patients.
We need to ensure that this country has access to the crucial
medicines it needs, Dr. Singh said. This is a national security
issue.
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