Clinton Responds to FDA Tripling Its Estimates For Heparin-Related Deaths
The FDA has now tripled its estimate for the number of deaths connected to the blood-thinning drug, heparin. The latest figures indicate that as many as 62 Americans have died because of allergic reactions to heparin products. The FDA's analysis came after we learned a Chinese factory used a cheap heparin substitute made from animal cartilage in heparin products sold in the United States by Baxter International. News reports have revealed that the Chinese factory "fell into a regulatory void" in China. And the FDA has admitted that it approved the drug for manufacture despite failing to inspect the factory because, according to the FDA, inspectors got mixed up and went to the wrong facility. After this came to light, the FDA suspended production of this Chinese-made heparin, and it is now warning 82 manufacturers of medical devices to insure that the heparin used in their devices is not contaminated.
In light of these reports, Hillary Clinton issued the following statement:
"When it comes to the threat of unsafe drugs from China, the Bush administration is sitting on its hands and rolling the dice with our safety. Heparin is the latest example. Americans have a right to know that their government is taking their health and safety seriously.
"With news accounts of a potentially tainted Chinese supply of the blood-thinning drug, heparin, and a new FDA report that the drug has caused hundreds of adverse reactions and 62 deaths, there is an urgent need for the administration to take decisive steps to protect patients from unsafe imported drugs. If George Bush won't start that process now, I will when I am president.
"As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance - and giving them a chance to clean up their act -- as we do now. And I will stiffen civil and criminal penalties for violators.
"It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick."