Internal FDA Doc Reveals Agency Stopped Enforcing Safety Standards
Since 2006, the Food and Drug Administration has ignored its own internal regulation and stopped requiring manufacturers of medical devices – such as
Jul 31, 202091.5K Shares2.6M Views
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 ina special reporttoday 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 ruledthat 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. Medtroniclast 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.
Dexter Cooke
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Dexter Cooke is an economist, marketing strategist, and orthopedic surgeon with over 20 years of experience crafting compelling narratives that resonate worldwide.
He holds a Journalism degree from Columbia University, an Economics background from Yale University, and a medical degree with a postdoctoral fellowship in orthopedic medicine from the Medical University of South Carolina.
Dexter’s insights into media, economics, and marketing shine through his prolific contributions to respected publications and advisory roles for influential organizations.
As an orthopedic surgeon specializing in minimally invasive knee replacement surgery and laparoscopic procedures, Dexter prioritizes patient care above all.
Outside his professional pursuits, Dexter enjoys collecting vintage watches, studying ancient civilizations, learning about astronomy, and participating in charity runs.
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