The article below from NYTimes.com
has been sent to you by tradergroupe@....
The Bush Adminstration in its move for tort reform is now blocking suits against drugs or medical devices where things go wrong. The reasoning is the FDA approved the drug or medical device so suits shouldn't happen because the drug or medical device worked when approved by the FDA.
How does the FDA approval process work?
Under current law, the Food and Drug administration must approve all pharmaceuticals and medical devices before they can be marketed. Although the process is often termed an FDA testing program,that agency does little if any actual testing. For example, the developer of a new drug uses its own labs or hires another private company to conduct animal tests on the drug for safety before proceeding to clinical trials for safety and efficacy in people. These tests often are conducted by a medical school department or a consulting firm. When each phase of the testing is completed, the pharmaceutical company submits the details of the testing process, evidence of adherence to FDA protocols, and the test results to the FDA. FDA officials review the test results at each step, and if they are satisfied, they give the pharmaceutical company permission to proceed to the next step in the testing process. When all the tests and trials are complete, FDA officials review all the information
often measured in hundreds of pounds or linear feet of reports rather than number of pages and decide whether the company can market the drug and advertise it to physicians for the treatment of specific diseases and conditions. This is why the approval process can take as long as 10 years and cost as much as $400 million.
So if the drug causes an adverse reaction or the heart implant device breaks down it's not the manufacturers fault. It's a government approved FDA okayed drug or device. And sorry about the bad news for your family.
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In a Shift, Bush Moves to Block Medical Suits
July 25, 2004
By ROBERT PEAR
The administration contends that consumers
cannot recover damages if the products have been approved
by the F.D.A.