FDA seeks on-the-ground oversight in China; heparin contaminant identified
The FDA has received approval from the U.S. Department of State to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.
That news couldn’t have come at a better time as the FDA announced yesterday that it has identified the contaminant found in batches of tainted heparin as chondroitin sulfate, a dietary supplement made from animal cartilage and used to treat joint pain.
The chondroitin sulfate had been chemically altered to mimic heparin, said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), during a conference call Wednesday.
The FDA has not determined whether or not the oversulphated chondroitin sulfate caused the allergic reactions and deaths in patients who were given the blood thinning drug.
Woodcock also did not say whether the agency believed the contaminant was intentionally or accidentally put into the crude heparin.
Chondroitin sulfate is less expensive than crude heparin and some federal regulators are suggesting that this case is similar to the pet food and toothpaste scandals, where cheaper, and apparently toxic, ingredients were substituted for more expensive conventional ingredients, according to the New York Times.
The latest move by the FDA to have inspectors on the ground in China is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months, according to the agency.
“The globalized economy demands nothing less than heightened regulatory interoperability, information exchange and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, MD, deputy commissioner for international and special programs for the FDA.
The FDA will be hiring five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.
That news couldn’t have come at a better time as the FDA announced yesterday that it has identified the contaminant found in batches of tainted heparin as chondroitin sulfate, a dietary supplement made from animal cartilage and used to treat joint pain.
The chondroitin sulfate had been chemically altered to mimic heparin, said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), during a conference call Wednesday.
The FDA has not determined whether or not the oversulphated chondroitin sulfate caused the allergic reactions and deaths in patients who were given the blood thinning drug.
Woodcock also did not say whether the agency believed the contaminant was intentionally or accidentally put into the crude heparin.
Chondroitin sulfate is less expensive than crude heparin and some federal regulators are suggesting that this case is similar to the pet food and toothpaste scandals, where cheaper, and apparently toxic, ingredients were substituted for more expensive conventional ingredients, according to the New York Times.
The latest move by the FDA to have inspectors on the ground in China is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months, according to the agency.
“The globalized economy demands nothing less than heightened regulatory interoperability, information exchange and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, MD, deputy commissioner for international and special programs for the FDA.
The FDA will be hiring five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.