Thursday, August 04, 2011
Counting on the govt to test new medical stuff?i
I am talking about devices—but testing of drugs is also sort of hazy.
Christine Mai-Duc, LA Times, July 30, 2011, talks about this. The National Academy of Sciences is recommending new systems for testing devices—such as hips inserted into living flesh. Who wants another operation to get out a recalled product?
One woman said recalls were for dishwashers and cars—not something inside her. Well, surprise.
Thousands of devices are cleared without clinical testing for safety or for effectiveness (whether they do what they say they will).
When the FDA got the job of testing in 1976, it said anything on the market could stay there without testing—and new devices could be cleared if they were “substantially equivalent” to existing products.
Two-thirds of high risk recalls from 2005 to 2009 went through the expedited approval process.
Still the FDA resists changing the system. Industry, for its part, says the FDA people are badly trained and gumming up the works.
Still—they too don’t want what they call a “vague new plan” with no useful guidance.
Soooo….best of luck.