Statement from Hillary Rodham Clinton
Since December, there have been nearly 450 individual reports of adverse reactions and as many as 21 deaths connected to contaminated shipments of the blood-thinning drug, heparin. The New York Times reported yesterday that the Chinese factory responsible for manufacturing a key ingredient of the drug "fell into a regulatory void" in China. The FDA has admitted that it approved the drug for manufacture despite failing to inspect the factory. According to the FDA, inspectors got mixed up and went to the wrong facility.
Today, the Times reported that the number of deaths associated with the contaminated shipments may be larger than previously thought. FDA has now told physicians to stop using heparin and production of the drug has been suspended.
In light of these reports, Hillary Clinton issued the following statement:
"When will the Bush administration finally get serious about the threat of unsafe drugs, food, and consumer products from China? How many more reminders do we need that our import safety net is badly frayed? The latest reminder is a potentially tainted supply of the blood-thinning drug -- heparin -- that has caused hundreds of adverse reactions and more than 20 deaths. The plant that produced a key ingredient for the drug was certified by the FDA to export to the United States even though the FDA had not inspected it or its suppliers, and neither had the Chinese government. Instead, FDA inspectors reportedly evaluated a different Chinese manufacturer with a similar name. The problems with the drug were first reported in January, and weeks later the FDA still doesn't have answers to important questions.
"This is unacceptable. Americans have a right to know that their government is taking their health and safety seriously. When I am President, I will take decisive steps to protect patients from unsafe imported drugs. 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."