Failed oversight

Tuesday, March 3, 2009 | 2:09 a.m.

In June 2005 a U.S. Food and Drug Administration inspector visited a North Carolina syringe manufacturer and found “several significant violations.” The company, AM2PAT, was filling syringes with saline and heparin that would be used to clean IV lines in people. The company promised to improve its quality control, and an inspection in January 2006 found satisfactory conditions.

But the following year the FDA started to receive complaints about the company. The liquid in the syringes was supposed to be clear, but doctors and patients reported seeing specks, sediment and discolored liquid instead.

Despite the complaints, an inspection in August 2007 found no serious problems, and the FDA didn’t start issuing recall notices until December 2007 — after the U.S. Centers for Disease Control reported a rash of illnesses linked to the syringes. The syringes were contaminated with deadly bacteria and have since been linked to the deaths of five people and the sickening of at least 100.

Federal prosecutors say the company knowingly violated the law by using untrained workers and failing to maintain quality standards. For example, the company’s “chief microbiologist” was a teenage high school dropout, a piece of equipment designed to test for contamination was broken, and ventilation for the company’s clean room — used to suppress the spread of germs — was an ordinary box fan patched with duct tape.

Two company officials pleaded guilty last week to charges connected with the case, and the company’s owner has fled from a 10-count indictment.

It is good that the federal government has pursued criminal charges against the company, but that is not enough. Congress should investigate the FDA’s role. The FDA apparently dropped the ball, ignoring obvious signs of problems at the company.

Congress should get to the bottom of the problem and fix it. The American public relies on the FDA to ensure that the nation’s drug supply is safe. Anything less is unacceptable.