Internal FDA Doc Reveals Agency Stopped Enforcing Safety Standards

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Wednesday, February 18, 2009 at 10:15 am

Since 2006, the Food and Drug Administration has ignored its own internal regulation and stopped requiring manufacturers of medical devices – such as pacemakers, heart valves and other life-sustaining inventions – to meet specific safety requirements before they are deemed safe enough to be implanted in humans.

As the Project on Government Oversight reveals in a special report today based on internal FDA document obtained by POGO,  senior officials within the FDA made this decision without public notice.  Manufacturers have been trusted to monitor themselves ever since.

The problem is particularly alarming because last year the U.S. Supreme Court ruled that patients harmed by these devices have no right to sue the manufacturers, if the device was approved by the FDA.

So now, the FDA is letting the manufacturers set their own safety standards, and the Supreme Court is shielding those manufacturers from lawsuits.

So who’s watching out for the hapless heart patient?

Update: Congress could step in to do that.  First, it could boost funding for the FDA and require it to enforce those laboratory safety standards the agency effectively discarded.  Second, it could pass the Medical Device Safety Act of 2008, which would nullify the Supreme Court’s decision in Riegel v. Medtronic last year and restore the rights of patients injured by medical devices to sue the companies that made them — restoring a critical incentive for manufacturers to ensure the safey of their own products.

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