Barry Meier has a truly intriguing article in the business section of The New York Times today that indicates that the Federal Drug Administration is not nearly doing enough now to protect the American people. In "Flawed Device Places F.D.A. Under Scrutiny", he reports that the FDA has neglected to act on a defective portable defibrillator that has failed to save lives.

Months earlier, in January, Access Cardiosystems' former chief executive, who had just been forced out, wrote the F.D.A. and accused Access of shipping potentially defective units. When F.D.A. inspectors visited the factory days later, they found no major defects and cleared the company of serious problems.

But as complaints about the device, and deaths possibly associated with it, began to increase over the summer, the inspectors never returned to learn what they might have missed.

Already under scrutiny for what some critics say is lax oversight of prescription drugs, the F.D.A. may have similar fault lines in its medical devices unit. Each year, the agency approves hundreds of devices, including dozens of so-called high-risk products. That category includes defibrillators, whose failure almost by definition is life-threatening.

With the sales of high-risk medical devices soaring, some experts say that the F.D.A may soon have an even bigger problem on its hands: The growing use of such devices in settings like offices, schools and homes puts them outside the agency's problem-reporting system.

[...]

A recent study in the October issue of The American Journal of Preventive Medicine found that the number of device-related deaths and injuries might be four times as great as reported to the F.D.A.

The real concern here is that Bush's FDA, for whatever reason, has not been doing an adequate job in ensuring the safety of the American people from faulty products. Grafs like this one do not reassure this blogger that the agency is at all competent.

Serious complaints were forwarded to the F.D.A. [about Access Cardiosystems, which makes the defibrillators] and officials there contacted the company for more information. But despite being put on notice about potential problems at the plant, inspectors never returned.

Check out the entire article for the rest of the scoop. It's disappointing to read about the inability of our government to properly regulate such devices, but it's nonetheless important to understand the degree to which this administration has declawed one of the few agencies that can truly save people's lives.