Lawmakers question FDA chief over heparin scandal; contaminant now linked to economic fraud
|The heparin scandal continues to be on the top of the FDA's agenda, as Sen John Dingell questions FDA cheif. |
Source: Zaz Report
Last month, the FDA confirmed some of the heparin contained oversulfated chondroitin sulfate, an altered version of chondroitin sulfate that's used as a dietary supplement and is typically made from animal cartilage.
The FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries—Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the U.S.
“It was apparently done, we suspect, by virtue of economic fraud,” von Eschenbach told the Senate Appropriations Committee's agriculture subcommittee in a 2009 budget hearing last week. In other words, the heparin might have been intentionally tainted to make money, but those facts are still unclear.
Rep. John Dingell, D-Mich., Tuesday accused von Eschenbach of “carrying the water” for the Bush administration, “toe-dancing around the hard facts,” and making promises that turn out to be nothing more than “hooey” in Congress, ABC News reported.
“Commissioner, I have no ill will towards you,” Dingell elaborated. “I have ill will of the most gross sort towards the fact that you come up here and defend a situation that is indefensible and that you are not soliciting the resources that you need to do your job to protect the American people the way the law says you should.”
Von Eschenbach agreed that the agency needs more resources, and estimated that an additional 500 inspectors and $70 million in funding is needed to enhance foreign drug inspections.
Last week, von Eschenbach told a Senate panel that the agency hopes to open three offices in China by October to increase U.S. inspections of plants that supply many of the active ingredients used in drugs sold in the U.S.
In response, Sen. Byron Dorgan, D-N.D., said that more than 40 percent of the active ingredients used in drugs sold in the U.S. are from China or India. Dorgan also noted that the FDA conducted 17 plant inspections last year in China compared with more than 1,000 in the U.S.
While von Eschenbach said he “completely concurs with the need to enhance our foreign inspections," he said that in the heparin case, plant inspections likely would not have caught the problem because the tests previously used to determine if heparin was safe would not have picked up the contaminant because it was so similar to the active ingredient in heparin itself. The agency said it has since developed a new test after receiving reports of the allergic reactions.
Also, on Monday, the FDA sent a warning letter to Changzhou Scientific Protein Laboratories (SPL), noting “significant deviations from U.S. Current Good Manufacturing Practice in the manufacture of active pharmaceutical ingredients,” in relation to the tainted heparin.
Both SPL and Baxter said they believe the contamination occurred at the crude level before it reached SPL’s Chinese facility that processes the crude material into the active ingredient. SPL also said the price of its raw materials for heparin ingredients increased, and therefore, the company said there was no way for an economic gain on its part.
Oversulfated chondroitin sulfate is chemically similar to the active ingredient in heparin, which is derived from pig intestines. FDA officials have said the contaminant is cheaper to make.
The active ingredient used to make Baxter's heparin was supplied by SPL, which has facilities in China and Waunakee, Wis., but the contaminated heparin has only been linked to China to this point. In response to the warning letter, SPL noted that the FDA did not reference its U.S. facility, only its Chinese plant.
The New York Times reported that Janet Woodcock, director of the FDA’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials conceded that heparin produced in their country contained a contaminant, though the officials claim it was not connected to the illnesses.
Currently, bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for April 29 in the House and May 1 in the Senate, according to the NY Times.