Consumers Union in a recent poll found most Americans believe safety is the FDA’s mission, so why then is the consumer group placing an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?”
Sounds like the answer should be a resounding ‘NO’ doesn’t it?
But that is exactly what happens.
Consumers Union would like to remind consumers that the FDA currently does not have the power to require a medical device maker to fix a defective design flaw that can injure consumers and at the same time serve as a predicate for other devices to follow. As incredible as that sounds, Consumers Union wants lawmakers to give the FDA the authority to require that a defective medical device be fixed and have to demonstrate the flaws have been fixed in subsequent devices.
“It’s time to close this absurd loophole and give the FDA the power it needs to protect patients,” says Lisa McGiffert who directs the Consumers Union Safe Patient Project. “Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients.”
After all, we don’t use runaway Toyotas as the template for other cars, or the formulation for Vioxx. But as the law stands we can use a defective surgical mesh, heart defibrillator leads or metal hips as the predicate or template for other devices to follow.
Take synthetic mesh. When defective ProteGen synthetic mesh was pulled from the market in 1999, that didn’t stop manufacturers from naming it as a ‘predicate’ for many of the other synthetic transvaginal meshes on the market today.
The safety loophole which is allowed to operate within the FDA is called 510(k). In fact more than 90 percent of medical devices are cleared for market through 510(k) which, unlike drug approvals do not require assurances of safety.
The approval process requires manufacturers to name a predicate medical device that’s already being marketed in order to obtain FDA clearance to sell. And you don’t even have to fix the defective medical device before naming it as a predicate again and again.
Under current law, the FDA does not have the authority to stop the approval or require the manufacturer prove the new device is safer.
This full-page ad is being launched as Congress gets ready to approve the medical device user fee act (MDUFA) which will double the amount industry pays for FDA reviews over the next five years. But industry wants something in exchange – quicker approvals and more industry oversight. Not exactly the picture the public has of our safety regulators?
McGiffert adds that the medical device lobby has blocked common sense reform demonstrated by the recent rejection of any consumer protection members in the Senate or House version of MDUFA.
Safe Patient Project Press Release:
MDND- FDA Closer to Funding Goals- Where is Patient Safety?