REDFLAGS ALERT

THE DANGEROUS FUTURE OF MEDICAL DEVICES

By Nicholas Regush

The FDA is disintegrating faster than a comet. It is bad enough that the agency has a deplorable record on prescription drug safety, but it has also never distinguished itself as a careful monitor of medical device safety.

But now, there is even more disaster in the making. It appears that the Bush administration thinks it is timely to introduce a new way of funding the FDA’s safety reviews of medical devices: let the manufacturers contract out product reviews to private companies.

Again, the argument is that the FDA needs money and technical help to do its job - and preferably much faster than at present. Again we hear about how important it is to get some of these products through the safety review quickly so that lives can be saved.

This is a long-standing argument used by industry that amounts to hallucination. We certainly don’t want more "life-saving" poorly-tested products such as breast implants out there.

Should the Bush administration be stupid enough to go ahead with this further dismantling of the FDA, look to major problems with medical devices in the years ahead. Just think about how the companies are going to choose the reviewers.

We needed this type of free-for-all legislation like a hole in the head.