Tuesday, January 29, 2008

What'dya Expect?

Mandates don't work if you can't enforce them:
The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign facilities, according to congressional investigators.

In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.
Pacemakers have historically been far safer than their more complicated cousins, defibrillators. Yet it is important to remember that nearly every recall or device advisory in recent times has been generated by either doctors evaluating the outcomes of their patients or by the development of concerning trends in device manufacturers' product performance, not FDA intervention. So why do we insist that the FDA inspect manufacturers biannually?

Probably because knee-jerk scare tactics work best at generating revenues for bureaucracy on Capitol Hill.


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