China Puts Drug-Safety Onus on Buyers

GORDON FAIRCLOUGH / Wall Street Journal 28feb2008

SHANGHAI — China's drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.

The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, "safeguarding the legality, quality and safety of active pharmaceutical ingredients" is up to importing countries.

In its statement, the agency also said it is cooperating with the U.S. Food and Drug Administration in the regulator's investigation of deaths and illnesses possibly related to the anticlotting medicine heparin sold in the U.S. by Baxter International Inc., of Deerfield, Ill. Some of the heparin used in Baxter's drugs was made by a Chinese joint venture of Scientific Protein Laboratories, a Wisconsin company that also makes heparin in the U.S.

Scientific Protein owns 55% of the joint venture; its Chinese partner owns the rest.

China's food and drug agency noted that the company in question is majority U.S.-owned, its production technology was supplied by Scientific Protein and all of its output was exported to the U.S. It also said that U.S. regulators "verified" in 2004 that Scientific Protein's China venture, Changzhou SPL, was supplying heparin.

It remains unclear if the heparin produced in China is connected in any way to the adverse reactions linked to the Baxter drug. Even so, the heparin case highlights regulatory gaps that have opened as drug companies have become increasingly global in their purchase of ingredients. China is supplying more of the international pharmaceutical industry's raw materials.

Lembit Rago, head of drug safety for the World Health Organization, says many Chinese manufacturers don't "have an understanding of international regulations or the training" to comply with them. Consumers in the U.S. and European nations are protected in part by their own regulatory agencies, Dr. Rago says. For other countries without the capacity to check drug quality, "it's a much bigger problem."

Yan Jiangying, spokeswoman for the State Food and Drug Administration, said that in China, producers of active pharmaceutical ingredients must be drug companies that are "registered and certified" by her agency. She said foreign buyers should check this certification and importing countries "should make strict tests" on ingredients and drugs.

Ms. Yan also says that her agency is working to "further strengthen cooperation" with the U.S. FDA on the monitoring of exports of active pharmaceutical ingredients. Andrew von Eschenbach, the FDA's commissioner, has said his agency needs a bigger budget to fulfill its responsibilities. Among its biggest challenges: coping with a rising number of drug imports.

Makers of crude heparin — who extract the chemical from pig intestines, often in small workshops, and supply this raw material to companies such as Changzhou SPL and other producers of refined heparin — say that they face little oversight from Chinese health authorities.

—Ellen Zhu in Shanghai contributed to this article.

source: p.D6 28feb2008

China SFDA:
Buyers Must Vet Drug Safety

ELAINE KURTENBACH / AP 27feb2008

SHANGHAI, China — China's drug safety agency, commenting on a probe into the recalled drug heparin, said Wednesday it enforces strict controls on chemicals used in pharmaceuticals, but that importing countries are ultimately responsible for ensuring product safety.

The State Food and Drug Administration, in a statement on its Web site, said it was cooperating with a U.S. probe into a factory that makes heparin, a blood-thinning drug by Baxter International that is subject to a massive recall due to adverse patient reactions.

"We attach high importance to this," the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.

But the SFDA said that based on international practice, "safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country."

Deerfield, Ill.-based Baxter recalled thousands of vials of the blood thinner and halted production earlier this month after it was linked to four deaths and hundreds of allergic reactions.

So far, the cause of the adverse reactions remains unclear.

The U.S. Food and Drug Administration is conducting inspections at a Baxter facility in New Jersey, at company supplier Scientific Protein Laboratories of Wisconsin and at Changzhou SPL, a factory in the eastern Chinese city of Changzhou that is 55 percent owned by Scientific Protein Laboratories.

China's SFDA said it also was investigating the factory, but gave no details.

The heparin scare is the first big issue to arise since Washington and Beijing signed an agreement in December that was meant to improve coordination on food and drug safety following a spate of scandals over tainted or substandard products.

FDA officials say cooperation has improved.

But the heparin case highlights the difficulties both sides face in improving oversight given paltry levels of staffing and funding on both sides. The FDA acknowledged that Changzhou SPL was never inspected by the FDA, contrary to its own regulations, due to what it says was a mix-up with names.

The Chinese food and drug agency apparently did not inspect the factory because it was classified as a chemicals manufacturer, not a pharmaceuticals company.

source: 28feb2008

China tells drug importers to take responsibility for quality KIRSTY BARNES / outsourcing-pharma.com 28feb2008

China's drug watchdog has revealed its stance on drug exports from the country: the bottom line is buyer beware.

The State Food and Drug Administration (SFDA) has said that while it does enforce its own strict controls on the chemicals used in pharmaceuticals, "safeguarding the legality, quality and safety of active pharmaceutical ingredients (APIs)" is ultimately the responsibility of the importing country.

According to the SFDA, companies that manufacture APIs in China must be registered and certified as pharmaceutical companies by the watchdog after it carries out an inspection of the facility. It is this authority that importing firms and the regulatory agencies of importing countries should look for before accepting any product from a Chinese company.

In addition, any importing country should also still conduct their own stringent quality control tests on APIs, excipients and finished drugs, the agency said.

Where it gets into a grey area is if a company is registered as a chemical manufacturer and not a pharmaceutical company, but still supplies chemicals to the pharmaceutical industry, as is believed to be not uncommon. In this case, the manufacturer is not subject to SFDA inspection and approval.

This was in fact the case with the Chinese supplier of the API for Baxter's heparin that was recently recalled form the market after a safety scare. This plant is now part of an investigation into the cause of the defective product - The SFDA has confirmed that the Chinese company involved was listed as a chemicals company and not a pharmaceutical company and was not registered with the agency as a heparin supplier.

Baxter has suspended the production of its blood-thinning drug heparin in multi-dose vials, following the deaths of four patients in the US who were given the drug in high doses, along with 350 reports of severe allergic reactions to the drug, with symptoms including a rapid drop in blood pressure, burning sensations, headaches, throat swelling and a shortness of breath.

It later emerged that it has emerged that the US Food and Drug Administration (FDA) has never inspected the facility in China where some of the API was sourced. The US watchdog has now said that that a team of inspectors is on its way to China to take a look at the plant in question and assess whether it may have played a role in causing the heparin side effects.

The identity of the Chinese plant in question has now been revealed as Changzhou SPL, a factory in the city of the same name. This facility is actually 55 per cent owned by Scientific Protein Laboratories, the company that also supplies the heparin API from a site in Wisconsin, US.

The FDA is conducting an investigation at both of these plants, as well as a facility owned by one of Baxter's subsidiaries in New Jersey, where the finished heparin is packaged.

The SFDA also indicated that it was assisting the FDA with its enquiries and was also conducting its own inspection of the Chinese site.

source: 28feb2008