13 yrs for FDA to inspect foreign drug plants PDF Print E-mail
Written by Stumo   
Thursday, 14 February 2008

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 Women’s 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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