The F.D.A. in Crisis: Another Danger Made in China

Editorial | The New York Times
February 03, 2008

The F.D.A. -- and American consumers -- got another warning last week about the need for vigilant monitoring of imported drugs from the developing world, especially from China. The contamination of a drug used to treat Chinese leukemia patients should also raise alarms at multinational pharmaceutical companies that plan to outsource manufacturing to China.

There is no sign that the leukemia drug was exported to the United States. So far, some 200 people in China appear to have been paralyzed or otherwise harmed. Given the manufacturer's expanding role in the export of drugs and active ingredients around the world, the lax practices revealed could sooner or later harm patients virtually anywhere.

The case was described last week in an article by The Times's Jake Hooker and Walt Bogdanich. Shanghai Hualian, a division of a huge state-owned pharmaceutical company, produced a leukemia drug that was somehow contaminated with another cancer drug during production. When the product was injected into the patients' spinal area, it caused paralysis and other side effects.

When Chinese regulators began to investigate the cause of the adverse reactions, plant workers tried to cover up what had happened, delaying corrective action. The government has now closed the factory and detained two company officials in a criminal investigation.

The same company is the sole supplier to the United States of the abortion pill known as RU-486. That pill is made at a different factory that passed an F.D.A. inspection in May and was inspected three times in recent months by Chinese drug regulators. Still, in light of the company's current difficulties, the F.D.A. would be wise to reinspect the plant promptly to ensure that the RU-486 production facility is adhering to rigorous quality control procedures.

This incident is one more frightening reminder of why Congress and the White House need to move quickly to strengthen the F.D.A. and other regulatory agencies to ensure that they can adequately monitor foreign producers and intercept dangerous products before they can harm American consumers.