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Device Makers Say They Favor Comparisons

Feb 26, 2009 | Parker Waichman LLP

Comparative Effectiveness, a component of the just-passed economic stimulus plan, is allegedly receiving favor by some top executives in the medical device industry.  Not everyone agrees.  Dow Jones reported that the industry supports the comparison only as long as patients are not narrowed to just one treatment option as a result of seeking cost savings.

"We can't afford a cheapest-at-best approach to medicine," said Bill Hawkins, chairman and chief executive of device maker Medtronic Inc. (MDT).  "Cheapest in the short run is not necessarily the best value for patients over the long term," reported Dow Jones.  The stimulus plan includes $1.1 billion for research that compares what drugs and devices are most effective for what purposes.  While Hawkins claims industry supports the research, media outlets say that industry lobbyists fought to have that element of the plan removed, said Dow Jones.

It is a well-known fact that the U.S. Food and Drug Administration (FDA) has long been criticized in recent years and, said Dow Jones, opponents have argued that the lack of resources has caused problems in agency operations and productivity, specifically in the area of medical device oversight.  Last month, prominent scientists at the FDA’s device division sent a detailed letter to President Barack Obama and Congress outlining a vast array of problems, said Dow Jones, citing a variety of issues involving corruption at managerial levels. 

Some industry experts from firms such as Edwards Lifesciences Corporation, Becton Dickinson & Company, Advanced Medical Optics Inc., and Medtronic, among others say they want to ensure Industry is not forgotten, said Dow Jones.  Industry is concerned over concern with costs could result in an "innovation blind spot," said AdvaMed President and CEO Stephen Ubl, according to Smart Brief, citing CNN.  Finance and Commerce explained that AdvaMed—Advanced Medical Technology Association—is comprised of local executives who were in Washington, D.C. yesterday to present AdvaMed’s policy and legislative and regulatory priorities for the coming year.

In his recent talk addressing a joint session of Congress, President Obama said that, “nearly a century after Teddy Roosevelt first called for reform, the cost of our health care has weighed down our economy and the conscience of our nation long enough.  So let there be no doubt: health care reform cannot wait, it must not wait, and it will not wait another year,” quoted Finance and Commerce.

In the past, said Finance and Commerce, when a company developed a new technology, device, or medication, it was simply required to present clinical data proving efficacy.  Now, with the creation of the Comparative Effectiveness Institute—a new regulator—financial data might also be reviewed to determine an innovation’s cost to Medicare as well as what long-term savings might be expected.

Although industry says it backs the move, it claims cost constraints could stifle innovation and cost lives.  But, following a recent report issued by Congress’s investigative group, the Government Accountability Office (GOA), in which it stated that the riskiest medical devices had not received sufficient FDA review, said Dow Jones, it seems increased oversight is called for.

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