Source:
Chicago TributeFDA inspections under fire after Chinese plant is found to have made key ingredient in Baxter's popular thinner, heparin
By David Greising | Tribune reporters
February 15, 2008
Baxter International Inc. used the Chinese operations of a small Wisconsin company to produce the blood-thinning drug linked to potentially deadly allergic reactions in hundreds of people.
Scientific Protein Laboratories of Waunakee, Wis., was shipping the active ingredient in the drug heparin, though American government health inspectors had not visited the production line in a plant outside Shanghai prior to production.
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But congressional sources said Senate investigators have learned that the U.S. and Chinese regulators are struggling to share information from multiple, disconnected databases maintained by the two countries. Training of Chinese inspectors is behind schedule, and communication systems between Chinese and U.S. regulators have had technical glitches, the investigators have found.
Problems persist, too, with the FDA's own enforcement measures. Two weeks ago Grassley asked the FDA to explain why it conducted only 11 inspections of Chinese plants in 2007, significantly fewer than the 24 in France and 18 in Germany, countries with a longer record of world-class production standards.
Read more:
http://www.chicagotribune.com/business/chi-fri_bloodthinnerfeb15,0,484368.story
The article doesn't have an eye-catching title, and the article is long - but the article gives very important information, and really should be read. It includes how widespread the practice of important key ingredients for US meds, or the meds themselves are (80% of drugs in the US), and that many more inspections of overseas production sites are conducted in countries that have strict regulations and not widespread problems (i.e., France and Germany) than in plants from countries with more problems such as China. The article implies that the FDA has left much of the role of ensuring safety to companies own inspections of their overseas facilities.
As I stated yesterday on a thread related to this story - it is a great irony that three or four years ago bushco made a big deal about the "problems" of individuals buying meds from Canada (cheaper), because these drugs were not tested, and thus might not be safe - when you read this and realize that there is a great potential that they aren't safe to begin with and the govt doesn't do much in the way to ensure safety. Whether it be due to costs (as in, more important to keep granting tax cuts to the wealthy and corps) than to fund basic functions of the govt to keep citizens safe (such as safety inspections), or due to taking the interests of priming the pump for greater and greater profits for Pharma (as in preventing folks from getting cheaper drugs from Canada - based on a public rationale which is absurd especially in light of this unfolding story) - it points to where the interests of this administration lies, and its not with regular citizens.
I encourage folks who open this thread to kick and recommend - I predict this will be a big unfolding story in the near future - and we should be aware of it/following it. But the thread title alone, is not likely to capture many readers attention unless it is up for a little while. Thanks.