Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers.

“The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems,” Bian said at a press conference.

China’s pharmaceutical industry is poorly regulated and several deaths and illnesses have been blamed on contaminated medications produced there. Last year, heparin manufactured in China was linked to more than 80 deaths and hundreds of illnesses in the United States. The blood thinner was later found to have been contaminated with a heparin-mimicking substance called oversulfated chondroitin sulfate, or OSCS. Heparin is derived from pig intestines, which are often produced by unregistered China businesses.

“I do not agree with what the foreign media say. The Chinese government has always paid a lot of attention to cracking down on fake drugs,” Bian told a news conference. “If the international community can give us information on fake drugs, we will resolutely investigate. There is no ambiguity about this.”

More than 300,000 cases of unlicensed drugs and medical products were distributed in 2007, according to SFDA.

Sources:
Associated Press
Reuters

SOURCE: Heparin Recall › China says tainted drug blame should fall on foreign suppliers

Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story.

Last year more than 80 Americans died and hundreds more became ill after they received injections of the blood thinner heparin. An investigation revealed that batches of heparin manufactured in China had been contaminated. The FDA later admitted it was not sufficiently staffed to inspect all foreign food and drug manufacturing plants.

Dr. Torti bypassed Dr. Janet Woodcock for the interim FDA commissioner post. Dr. Woodcock was the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. She had been favorite choice for the post by pharmaceutical manufacturers. Congressional critics claimed she was too closely tied to pharmaceutical groups and cited serious drug safety issues under her watch, including the tainted heparin scandal.

SOURCE: Heparin Recall › Torti named interim commissioner of FDA

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Heparin Recall › doctors favor drug safety litigation