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FDA Discusses News Reports That Agency has Withheld Information on...



In a podcast posted to Eye on FDA (http://www.eyeonfda.com/) by Mark Senak, Senior Vice President at Fleishman-Hillard in Washington, D.C., the Food and Drug Administration discussed reports that the agency has been withholding information from Congress regarding specific Chinese companies that manufacture heparin due to the existence of confidentiality agreements.



In February 2008, the FDA announced that Baxter International had temporarily stopped manufacturing multiple dose vials of heparin, a blood-thinning drug, due to reports of serious adverse events resulting in death. Since that time, reportedly 81 people have died and contamination has been discovered in eleven nations and products of multiple manufacturers.



The FDA has been conducting an investigation of the drug, and Congress has been holding hearings over the FDA's investigation and has delved into questions about how the heparin came to cause the adverse events.



On May 12, reports surfaced when The Wall Street Journal ran an article under the headline that stated "FDA Withholds List of Chinese Manufacturers From Probe" that suggests the FDA has been withholding information about Chinese manufacturers who develop components of heparin due to confidentiality agreements. On May 16, Mark Senak sat down with FDA spokespeople from FDA's CDER to get their take on these reports and will publish the conversation in a podcast (http://www.eyeonfda.com/eye_on_fda/podcast/index.html) to be posted on Eye on FDA (http://www.eyeonfda.com/) on May 19, 2008.



Mark Senak's 'Eye on FDA'


'Eye on FDA' has a diverse 'readership', including national media, government officials, patient groups, law firms, stock analysts and pharmaceutical companies themselves.






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