From the NYT:
Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators from the GAO have concluded.
'In recent years, the accountability office, Congress’s auditing arm, has chastised the F.D.A. as failing to put into effect its own plan to protect the nation’s food supply, as failing to adequately inspect the foreign drug plants that provide most of the nation’s medicines and as being so hobbled by bureaucratic infighting that it fails to detect emerging drug dangers.
Each time, the agency has largely agreed with the investigators’ findings and promised to do better. The difference this time is that nine scientists within the agency’s device division are echoing critics’ claims of a corrupted review process.'
More here.
This should not come as a surprise, since the alarm has been sounded for years now. Nonetheless, with a failed system desperately in need of a ground up repair, courts simply shrug their shoulders and rely on a preemption preamble to shield device makers from being held accountable in a court. The FDA in its current form is a disgrace to the american public.
This same week, another report shows the mess that is the BPA investigation (the ingredient in some plastic bottles, including baby bottles). From the Trib:
"In late October, an advisory panel to the FDA found fault with the agency's conclusion [regarding BPA]. The panel said that the FDA had only considered studies financed by the plastics industry and had ignored evidence of the potential harm from BPA. The FDA created "a false sense of security" about the safety of BPA, the panel said." Link.
Got that? The FDA ignored evidence it had before it. Should Americans be frightened?
