The Frightening Heparin Case

-NY Times

04/28/2008 - The story of a deadly, contaminated blood thinner has laid bare serious deficiencies in the regulatory oversight of drugs imported from China and other developing countries. Congress is rightly determined to plug holes in Food and Drug Administration procedures that leave the American public vulnerable to toxic imports. But that is only half of the problem. It also must ensure that American companies, eager to cut costs by outsourcing, are especially diligent about monitoring their suppliers.

The F.D.A. has now linked contaminated batches of Chinese-made heparin to 81 deaths in the United States. The agency says the contaminant has been found in the drug supplies of 10 other countries as well, although only Germany has reported illnesses associated with it.

Chinese officials, while acknowledging the contamination, deny that it has caused any deaths. Research published in leading scientific journals suggests otherwise. Scientists at the Massachusetts Institute of Technology found that the contaminant activates two inflammatory pathways in the body that can lead to a dangerous decrease in blood pressure or to a severe allergic reaction. Normal heparin does not.

Whether the contaminant was introduced through sloppy manufacturing processes or was deliberately added is unclear.

Two Congressional hearings last week reinforced contentions that the F.D.A. is short of the money, manpower and legal authority it needs to cope with the flood of drug imports. The current regulatory structure was established to oversee domestic companies. It has not evolved to handle today’s global marketplace, in which more than 80 percent of all active ingredients in drugs sold here are made in other countries, with an increasing portion coming from China and India.

Congress needs to ensure, through adequate financing, that the F.D.A. deploys more inspectors abroad. The administration needs to press for agreements that will allow inspectors to examine foreign factories. Inspectors may not be able to spot every problem, but the prospect of regular inspections would surely goad legitimate manufacturers to clean up their processes.

That said, the primary responsibility for ensuring the safety of this country’s drug supply clearly rests with the American companies that import active ingredients from low-cost foreign manufacturers. They are in the best position to supervise their suppliers, demand that they follow good manufacturing processes and punish them — by rescinding a contract — if they fail to do so. All companies must ensure the quality and safety of what they buy and what they sell.