The U.S. Food and Drug Administration (FDA) called the contamination a "worldwide problem" that has been seen in 11 countries, including the U.S., and has been linked to as many as 81 deaths.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the contamination is a "worldwide problem" and has been linked to as many as 81 deaths in 11 countries, including the United States. Janet Woodcock, director of the CenterforDrugEvaluationandResearch under the FDA, said that heparin contaminated with chondroitin polysulfate has been traced to 12 companies in China.
Woodcock's comments came hours after the Chinese government began to "push back" against the FDA's conclusion that chondroitin polysulfate was linked to adverse reactions and that the source of the contamination was China.
Officials at the Chinese Embassy in the U.S. strongly disagreed with the FDA's assertion that the Chinese company was responsible, noting that the problem began in the U.S. Chinese health officials said at a news conference Monday morning that they intend to visit a heparin plant in New Jersey this week.
Jin Shaohong, deputy director of the National Institute for the Control of Pharmaceutical and Biological Products in China, said chondroitin polysulfate was not the source of the problem.
The FDA rebutted China's contention that the contaminant was not definitively linked to allergic reactions. We note that our Chinese counterparts are skeptical that such a link is clear, Woodcock said.
Jin Shaohong, deputy director of the China National Institute for the Control of Pharmaceutical and Biological Products, argued
that the heparin contaminants were not definitively linked to allergic reactions, and that the outcry over questionable Chinese-made medicines, pet food, toothpaste, catfish and leaded children's toys has led the U.S. Congress to call for legislation to tighten regulation of imported food and drugs and for the FDA to impose stricter inspections on Chinese factories that export food and drugs to the United States. The FDA has been asked to impose stricter inspections on Chinese factories that export food and drugs to the United States. If stricter import regulations are implemented, it could have an impact on low-cost drug manufacturing centers, and the U.S. pharmaceutical industry could be in trouble.
The methods China uses to screen for contaminants may be one of the key reasons why the FDA and China have come to diametrically opposed conclusions. MohedNasr said the Chinese tests were not refined or sensitive enough to effectively detect trace amounts of contaminants.
BaxterInternationalInc., an Illinois-based seller of pharmaceutical heparin, recently recalled a large number of heparin products. Japan, Australia and some European countries have also issued warnings or implemented recalls.
Chinese officials said the uncontaminated heparin was linked to 100 adverse reactions, 25 of them serious.The FDA said China's analysis was in error and that batches of the drug tested by the Chinese were later found to be contaminated.
Baxter also disagreed with China's claims. A spokeswoman for the company, Erin? Erin Gardiner pointed out that the drug lots for which we received adverse reaction reports contained contaminants.
The Chinese government's public relations campaign against the FDA comes just as the FDA issued a warning letter to Changzhou SPL, China's leading heparin maker, saying it had failed to effectively respond to the FDA's earlier concerns about conditions at its plant. ChangzhouSPL is a China joint venture plant of Wisconsin company ScientificProteinLaboratoriesLLC, which is Baxter's main heparin supplier.
Changzhou Kep said they believe the warning letter does not reflect the actual status of Changzhou Kep's compliance with current manufacturing standards.The FDA said the contaminant appeared to have entered the supply chain before Changzhou Kep became involved.
FDA Commissioner Andrew Von Eschenbach testified before a Senate committee last week that the contaminants were intentionally added to the heparin during the manufacturing process, and that the adulteration was an economically motivated attempt to expand the supply of the drug at the source. The Chinese government later reacted to that.
U.S. Secretary of Health and Human **** Services Mike Levitt (D-Michigan) said that the Chinese government's response to the incident was "not a good idea. Leavitt (MikeLeavitt) told the media on Monday that the United States and China have worked well together on the agreement signed last December, which has put more pressure on the Chinese government to regulate exports of food, drugs and medical devices. Levitt said the two sides have had some disagreements, but have had some success in working with each other.
On Tuesday, the House Committee on Energy and Commerce will hold a hearing on the FDA's lapses in foreign food and drug imports. Given that the FDA commissioner will also testify, a new U.S. polemic with Chinese health officials could surface