Wednesday, July 28, 2010

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin


In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."


The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.


To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

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