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2006: A Year of Upheaval


The year 2006 was full of excitement, but not always for the right reasons. There were several major developments, some of which were unfavorable to the device industry.

The industry's top-selling product, drug-eluting stents, saw sales fall as studies questioned whether they are too much of a risk because they could cause blood clots. FDA determined that they are safe and effective if used as approved, but 60% of the time they are not used as approved, and the negative publicity made skeptics out of some doctors and patients.

Another top-selling product, implantable cardioverter-defibrillators, continued to attract media attention over malfunctions, and prompted intense debate over how FDA should handle recalls of such devices.
These developments created headaches for Boston Scientific, a player in both technologies thanks to its acquisition of Guidant, and Johnson & Johnson, which decided to shell out for Conor Medsystems in hopes of landing a superior next-generation stent technology.

Government fared no better in the public eye. FDA commissioner Lester Crawford resigned under a cloud, undone by failing to sell off stocks in FDA-regulated companies.

CMS administrator Mark McClellan took off in mid-reform effort, enticed by the private sector. Critics of silicone breast implants howled over FDA's decision to allow them back on the market. And key members of Congress continued to berate FDA for inadequate postmarket surveillance. The latter prompted CDRH to come up with a plan to overhaul how it handles postmarket information—and how the agency interacts with device firms in that sphere.

Such events may seem better suited for gossip columns than MD&DI, but the situations produced valuable lessons for industry, clinicians, and regulators to learn. Many of them are explained in the stories below.

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