FDA rips Europe's system for medical device reviews

  • Article by: JIM SPENCER and JAMES WALSH , Star Tribune
  • Updated: April 22, 2012 - 9:33 AM

Agency disagrees with device makers who see Europe as a model for product approvals.

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davehougApr. 22, 12 8:26 AM

Industry-driven measures also aim to change the FDA's mission statement to include job creation. - - - We saw how well it works out when the watchers are also the industry promoters in the Gulf Oil Well Disaster.

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debbiedownerApr. 22, 1210:44 AM

The FDA is a politically oriented agency that also has staff that engages in insider trading on medical device and pharmaceutical companies. It is an embarrassment.

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luzhizhenApr. 22, 1211:29 AM

Europe also approved Thalidomide before the USA did - if anything, we should tighten up the rules and testing of this stuff - even though the Chamber of Commerce, Medtronic, St. Jude, etc. don't like it.

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smeeagain2Apr. 22, 1211:37 AM

This from the government agency that allows poisons to be put in our food products. Hmph!

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evilgrimaceApr. 22, 1211:46 AM

Why regulate at all? Is the FDA in the Constitution?!? Just let private businesses put out whatever they wish and let the free market sort it out! Ron Paul 2012!

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timo84Apr. 22, 1212:16 PM

The real question is....who do you want making medical decisions for you - you and your doctor, or some Washington beaurocrat? I have personally dealt with the FDA, and in my experience the people making decisions on the approval don't understand what the product even is. We complain about health care costs, and then we require clinical studies that cost hundreds of millions of dollars and take years, while the products may have been sold for years in the EU, Canada, Japan, Australia, etc.

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irvine93Apr. 22, 12 1:25 PM

The FDA should have approved the cap mentioned in the story, if it was comparable to drugs. One has to wonder whether the FDA is trying to protect the drug companies. Any drug, including the ones that literally are saving lives, has side effects. So if a medical device is comparable to a drug, why not approve it? The comment, above, about Thalidomide is not accurate. The drug did not make it to this country thanks to the original act that demanded safety of new drugs. Still, it was enough to change the act to determine efficacy and since them millions suffered and died waiting for a life saving drug to come through rigorous and expensive studies. Worse, if a drug is helping "only" 1% of ill people, it will not be approved. What if the FDA commissioner, or a member of Congers falls into this 1%?

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halfabubbleApr. 22, 12 1:38 PM

The FDA is messed up. On one hand they've allowed free and clear sailing for some medications and devices which were later recalled and removed from the market. On the other hand, they've held up innovation and out right rejected medications and devices which have been in use for years in other countries. The biggest problem for industry is they never know which FDA they are dealing with, and when you run into the overly restrictive FDA, it gets frustrating because no amount of history, science or data you generate will change their minds, even if there is a similar device or drug on the market already. And lets be honest here, there is no way to know for 100% certainty that after approval, something isn't going to fail, despite all sorts of testing.

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hobie2Apr. 22, 12 4:00 PM

Free market medicine... there's a concept... Always trust the company that sells snake oil... it's been helping people for a hundred years. And their salesmen aren't driven by money, but by a need to help humanity. It's just so obvious... We need politicians who are also driven by their need to help mankind to get in there and stop government departments like the FDA from chasing money at the expense of human health and lives. Hellooo....

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hobie2Apr. 22, 12 4:10 PM

..."The FDA should have approved the cap mentioned in the story, if it was comparable to drugs." It wasn't. The cap used surgery - the part where they open your chest with a knife and saw and cut apart your cartilage and muscles and wrap a baggie around your beating heart, working it around the veins and arteries feeding the heart and then sewing and stapling you back up - the other used chemicals. If the surgical procedure would have shown to have been effective, it would have been allowed. You have to compare patient walking in the doctor's office to finish who survive, not compare after surviving surgery to finish who then survive. And then if they are near even then, the cost of deliveries.

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