Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured in China. An investigation found that batches of heparin manufactured in Baxter International’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but cause adverse reactions and even death.

Years ago most drugs were manufactured in the U.S., but over the years those operations have moved overseas – in particular, to Asia – where labor, construction, regulatory and environmental costs are lower. The FDA also inspects domestic plants far more often than foreign ones, which also adds to pharmaceutical companies’ production costs.

Following the heparin contamination last year, the FDA admitted that it was not sufficiently staffed to inspect all foreign offices. Thus, the agency has since begun to set up offices in foreign countries. To date, offices have been placed in China and India. The FDA also launched a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S.

SOURCE: Heparin Recall › Lawmakers call for rule requiring drugs be made in U.S.

The news is a double-blow for Europeans, not only for the 43 employees who lost their jobs, but for consumers who have expressed concerns about the quality of drugs and other products made and manufactured in China.

Products made in China have been continuously under fire for the past several months, from milk tainted with melamine to toys covered with toxic lead paint. Earlier this year lots of the blood thinner heparin manufactured in China were recalled after more than 80 Americans died and hundreds more fell ill after receiving doses of heparin. Select batches of heparin were found to have been contaminated during production at Baxter International’s China plant.

Since then, the FDA has announced plans to better track imports of food and drugs. One of its first steps was to open three offices in China to oversee quality control standards of products imported to the United States. Another 50-plus offices will be opened worldwide, though the agency says it could take years to effectively inspect all foreign facilities.

According to Bloomberg, China has more than 700 plants registered to ship drugs to the United States – more than any other country.

SOURCE: Heparin Recall › Europeans now dependent on China for Panadol, Tylenol

This new method is easier and less expensive than analytical methods used previously, such as nuclear magnetic resonance and capillary electrophoresis. Meyerhoff and his team detailed the research in the journal of Analytical Chemistry.

Oversulfated chondroitin sulfate in batches of heparin manufactured in China were responsible for serious allergic reactions that earlier this year killed more than 80 Americans and made thousands more ill.

Heparin was only one of the many products made in China in the past several months was were found to be unsafe for humans and animals. As a result, the FDA vowed to place more than 60 food and drug regulators worldwide over the next year as opposed to sending staffers on individual assignments to inspect foreign facilities. The agency’s first office opened in Beijing Wednesday. Additional Chinese outposts will open in the next few days in Shanghi and Guangzhou.

Earlier this week, HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach joined China’s minister of health, Chen Zhu, in a workshop on food safety that focused on policy and government reforms, according to a CNN story about the opening of the Beijing office.

“The government should not just respond to the incident but find the root of it,” CNN quoted Chen in a news conference Wednesday in Beijing.

SOURCE: Heparin Recall › Researchers find new method to detect contaminant in heparin