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Tainted Leukemia Drug Company Shut Down in China

Dec 14, 2007 | Parker Waichman LLP

China's food and drug safety agency has revoked the license of a company responsible for making tainted leukemia drugs that are being blamed for causing leg pains and partial paralysis in dozens of patients.  State-owned Shanghai Hualian Pharmaceutical Co. is a unit of China's biggest drug maker Shanghai Pharmaceutical (Group) Co. and, in a statement made by the State Food and Drug Administration (SFDA) on its Web site today, the company will also be fined the highest amount allowed under law; profits from the sale of the contaminated drugs will be confiscated.

According to an SFDA statement, some Shanghai Hualian executives were detained by police on suspicion they deliberately withheld information about violations of production standards during the investigation. A report in the state-run newspaper Shanghai Daily said the maximum fine for a breach of regulations was only $4,000.

Shanghai city government officials said they were cooperating with the SFDA in resolving the case. Calls to Shanghai Pharmaceutical went unanswered Thursday morning and calls to numbers listed for Shanghai Hualian Pharmaceutical were answered with a recording indicating that the number does not exist.

The investigation into Shanghai Hualian Pharmaceutical was one of many involving contaminated or bogus drugs and foods prompting tighter safety regulations enforcement.  The SFDA described the company's actions as a systematic cover-up. 

Authorities banned the sale and distribution of the drugs in early July after some patients complained of adverse reactions.  In September, the SFDA ordered the company to stop production of the drugs involved—methotrexate and cytarabin hydrochloride—withdrawing most of them from the market.  The investigation revealed the drugs were contaminated with vincristine sulfate—another cancer-fighting chemical—during production, the agency's statement said.  Investigators did not say how contamination occurred but put the number affected at over 100 while local news reports stated several hundred patients suffered adverse reactions.

Shanghai Hualian—founded in 193—is one of the country's top drug makers, exporting to over 70 countries and regions globally, according to its Web site.  China has taken a series of steps to crack down on tainted drugs and other unsafe products after various foods, medicines, and other items ranging from toothpaste to seafood were found to contain potentially deadly substances.  The issue of safety was on the agenda of high-level China-U.S. economic talks this week in Beijing and both governments signed deals on safeguarding the quality of food, drugs, and medical devices and setting up bilateral mechanisms for sharing information on goods exported to the U.S.

In China's harshest action on safety so far, the country's former top drug regulator was executed in July for taking millions of dollars in bribes to approve substandard medicines, including an antibiotic that killed at least 10 people.  Earlier this week, the SFDA announced a new procedure for drug recalls that is expected to encourage pharmaceutical manufacturers to take such actions voluntarily.  Companies that issue recalls on their own will face no penalties or less stringent penalties for safety violations; those who knowingly fail to do so will face heavier punishment and possibly lose their licenses.


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