FDA Discusses News Reports That Agency has Withheld Information on Chinese Drug Manufacturers of Heparin from Congress on Eye on FDA Podcast

In a new Eye on FDA podcast, blogger Mark Senak interviews FDA spokespeople regarding recent reports of information about Chinese drug manufacturers of heparin being withheld from Congress.

Washington, D.C. (PRWEB) May 19, 2008 - In a podcast posted to Eye on FDA 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 to be posted on Eye on FDA 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.

# # #

Simillar Articles

		Mark Senak's Eye on FDA Successfully Launches Monday Podcast Series
		The podcast interviews, published each Monday on Mark Senak's Eye on FDA, explore the US regulatory landscape and how it is impacting the current environment for pharmaceutical and...
		Eye on FDA Launches New YouTube Channel to Aggregate Healthcare Videos
		Eye on FDA, a specialty blog written by Mark Senak, Senior Vice President at Fleishman-Hillard in Washington, D.C., launches a new YouTube channel. The Eye on FDA YouTube channel will aggregate...
		LegalView is Proud to Announce the Launch of New FDA Notification Service
		LegalView recently launched its U.S. Food and Drug Administration (FDA) notification service, which will allow individuals suffering from negative pharmaceutical side effects to voice their...
		LegalView Expands Baxter Heparin Information Portal to Include Information on an Additional...
		LegalView updated its Baxter Heparin information portal to add information on the most recent recall of the blood-thinning drug. Heparin, which is used to control blood during surgical procedures,...
		LegalView Updates Its Baxter Heparin Information Portal With News of Ongoing United States and...
		LegalView recently updated its Heparin information portal on the latest news regarding the contaminated batch of Heparin, which may have sickened hundreds and caused the death of up to 90...