Tuesday, November 29, 2011

Is the FDA promoting or precluding medical innovation?

I have been working with a number of medical device clients lately, and I've been struck by the frustrating delays in bringing new innovative products to market.

"U.S. investment in medical devices is falling...yet the FDA is demanding more drug-like trials for devices, causing many of the delays in getting new products to U.S. consumers," says Dr. Scott Gottlieb, a leading physician and deputy commissioner of the FDA from 2005-2007.

In a recent opinion piece in The Wall Street Journal, Gottleib refers to data from PricewaterhouseCoopers and the National Venture Capital Association showing the number of newly started, venture-backed medical-device companies fell to 60 in 2010 from 118 in 2008. "The magnitude of these declines dwarfs those seen in other entrepreneurial sectors. It can't reasonably be ascribed to the struggling economy alone," he asserts.

Gottleib references a 2011 study by the Boston Consulting Group of European device approvals that suggests that Europe's more expedited process is just as rigorous and safe as the FDA's. 

"Devices are also tools in the hands of physicians. The benefits of a device are ultimately dependent on how it is used by a physician," writes Gottleib. "A stethoscope, for example, only needs to show that it can enable a doctor to hear heart sounds. A stethoscope should not have to prove that using it can reduce the complications from heart failure."

He concludes, "This is no way to run a regulatory process if the FDA is serious about promoting medical innovation and advancing the public health."

Click here to read his entire article at http://online.wsj.com

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