Commentary: Regulators too slow to crack down on company

This editorial appeared in The (Raleigh) News & Observer.

The existence of the Federal Bureau of Investigation doesn't prevent people from robbing banks or committing bribery. But the more robust the FBI, the more effective it will be in deterring crime and catching crooks.

The existence of the federal Food and Drug Administration can't prevent greedy, amoral people from sending contaminated products into the marketplace. But an FDA clearly starved for resources and leadership can make it easier for these crooks to carry out their schemes, sometimes with deadly results.

That appears to be exactly the situation that enabled a company to ship medical syringes tainted with infectious crud from its packaging plant in Angier. The fluid in the syringes sickened upwards of 100 patients and killed five, federal prosecutors now say. Two company officials have pleaded guilty and the indicted CEO is on the lam, perhaps having fled to his native India.

These culprits deserve what the justice system throws at them. But what about the regulatory failures that this scandal spotlights?

The N&O's reporting has made it painfully, disgustingly obvious that the company, AM2PAT, didn't give a flying flip about its obligations to test the heparin and saline it was loading into syringes for shipment to hospital and clinics. Testing requirements either were ignored or results were falsified.

The FDA in late 2007 began ordering the company's products recalled. But reports of foreign material in the syringes first were lodged in 2005. In fact, the agency that year notified AM2PAT that it had found nine serious rules violations at its plant, then located in Wake County.

The company moved its operations to Angier in mid-2007. It wouldn't have taken Sherlock Holmes to deduce that the place was a public health fiasco in the making. Assuming, that is, that Holmes or his FDA counterpart ever showed up to inspect the place.

To read the complete editorial, visit The (Raleigh) News & Observer.

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