BEIJING - In a case that closely parallels FDA's investigation of the drug heparin, China's State FDA is now examining a biopharmaceutical that triggered severe adverse reactions in seven Chinese patients, six of whom have died.

The speed with which the SFDA responded to the adverse reactions by investigating the case, ordering a recall of the drug and reporting it to the public is being hailed by industry observers as a sign of remarkable progress.

The drug regulator's rapid response was launched after the Second Hospital attached to Nanchang University in the southern Chinese province of Jiangxi issued an adverse reaction report upon the death of a sixth patient injected with human immunoglobulin on May 28.

By that evening, the SFDA had begun coordinating with the governor and vice governor of Jiangxi and with provincial drug regulators to create a special task force to investigate the case.

Within 24 hours, the SFDA had instructed the maker of the drug, Jiangxi Boya Biopharmaceutical to stop sales of the blood-based product and to recall an entire batch of more than 6,000 doses of the medicine. The manufacturer denies any errors in its production process and says it not been asked to stop production (PharmAsia News, June 9, 2008).

The SFDA has issued a series of bulletins on its Web site to warn hospitals throughout the country about the adverse reactions and to post updates on its investigation.

"The State Food and Drug Aministration has acted with remarkable speed in this case, first in ordering the recall of the drug, and then in examining the product for any irregularities," Richard Liu, an attorney at the law firm Lifang & Partners, which specializes in pharmaceutical regulations, told PharmAsia News.

Liu added that the SFDA's handling of this adverse event has been a model of efficiency and professionalism.

The head of SFDA, Shao Mingli, travelled to Jiangxi to personally head up the investigation, and the administration's National Institute for the Control of Pharmaceutical and Biological Products is conducting fast-track examinations of the recalled product.

The regulator is apparently launching a new era of transparency in handling public heath hazards like the present case, Liu said.

"The SFDA has issued frequent reports on these adverse reactions, and is using the Internet to spread the latest information across the country," he said.

The health regulator's measures aimed at preventing any more adverse reactions and deaths due to the antibody drug features a number of similarities, but also contrasts, with the recent handling of scores of extreme reactions and fatalities in patients administered the drug heparin in the United States.

When U.S. investigations into the heparin-triggered deaths led to the finding that a contaminated version of the drug had been produced in a Chinese workshop, Chinese regulators called on to help track down the tainted product had been perceived as somewhat hesitant in agreeing to a joint U.S.-Chinese taskforce (Also see "U.S. FDA Pinpoints Culprit In Bad Heparin" - Scrip, 22 April, 2008.).

But this time, SFDA acted swiftly to contain the problem and to keep the public informed.

The heparin controversy has caused SFDA to become more stringent about drug investigations and about guaranteeing the safety of drugs made in China, said Ming Pang, who heads the Hong Kong-based, pharmaceutical-tracking Eastway Consultants Ltd.

Late last year, American and Chinese health regulators signed an agreement that provides for closer cooperation in the examination, tracking and trade of a wide range of food and drugs. The FDA has also unveiled plans to set up offices staffed with inspectors in three American diplomatic outposts in China over the next year and a half (Also see "U.S. FDA Plans Permanent Offices In China In Wake Of Heparin Scare" - Scrip, 17 March, 2008.).

Earlier this month, Deputy Commissioner of the State Food and Drug Administration Wu Zhen met with Roger Williams, who heads the United States Pharmacopoeia, to work out an agreement for closer cooperation between the two groups, according to a report issued on SFDA's Web site.

Wu was quoted as saying SFDA's National Institute for the Control of Pharmaceutical and Biological Products "would enhance cooperation with the United States Pharmacopeial Convention and introduce new equipment and technology for drug control so as to improve the drug control ability of China."

The deputy commissioner added that "further interchange and cooperation should be carried out in the fields of drug standards and certification."

- Kevin Holden (pharmasia@elsevier.com)

China’s SFDA Rapid Response To Biopharmaceutical-Triggered Deaths Seen As Progress By Industry Observers

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