The FDA's Not-So-Simple Choice on Regulation of Medical Devices
The U.S. Food and Drug Administration (FDA) is caught in a classic bind between the demands of industry and consumer advocates in its efforts to better regulate the medical device manufacturers.
If the FDA caves in to industry demands that it weaken -- or at least not strengthen --regulation of medical devices, some patients will continue to be hurt by devices that haven't been properly tested. But if the agency toughens its regulatory stance, the device makers argue, many promising devices will never make it to market -- purportedly harming patients who won't be able to benefit from them.
Unlike drug manufacturers, medical device makers usually don't have to prove that their products are safe and effective if they're similar to other devices on the market. Some well-publicized device failures have increased pressure on the FDA to change that policy. But significant changes would cost the device industry billions of dollars and slow the entry of new products to the thriving market. So, after receiving industry comments, the FDA announced it will "streamline" the approval process and punt the main issue to the Institute of Medicine (IOM).
The IOM is expected to release its recommendations to the FDA this summer. But it's unclear where it will come down on this complex issue.
Meanwhile, the FDA says it will make a couple of dozen changes in its approval process, including a provision for faster review of low-risk devices. These steps will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly," said Jeffrey Shuren, head of the FDA device unit.
Shuren's remark is a pretty strong indication that the FDA is buying the industry line. Another sign is the FDA's decision to defer to the IOM, rather than making a decision now on the tougher issues, which include the possibility of requiring human testing for a subset of new devices.
The device industry is delighted over the FDA's stance. Referring to the current FDA approval method, known as the 510(k) clearance process, Steven J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), the device makers' trade association, said this:
Much of the agency's plan supports our long-standing position that the 510(k) process is fundamentally sound and has been beneficial to American patients. The plan also generally adheres to our principles that any changes to the 510(k) process should be targeted, have a corresponding health benefit and support timely access to new treatments and cures... FDA's plan drops or defers for IOM review many proposals that would have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits.
Well, here's a health benefit: In 2007, Medtronic was forced to recall its Sprint Fidelis lead wires following hundreds of reports from patients with defibrillators who were being shocked unnecessarily or having their heart device fail to deliver any shock when one was needed.
Here's another health benefit: Undisclosed defects in defibrillators made by the Guidant Corp. allegedly caused the deaths of six patients. Guidant, part of Boston Scientific (BSX), settled 4,000 claims in 2007 but is still facing an array of lawsuits.
The glory of U.S. medicine is that it's on the cutting edge of new medical discoveries. The shame of U.S. medicine is that we're all guinea pigs.
Image supplied courtesy of Wikimedia Commons.
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