Scott Gottlieb, a former Food and Drug Administration deputy commissioner and resident fellow at the American Enterprise Institute, says government over-regulation is costing tens of thousands of Americans to lose their lives unnecessarily, and driving medical device businesses overseas.
"Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials," Gottlieb writes in The Wall Street Journal. "This is no way to run a regulatory process if the FDA is serious about promoting medical innovation and advancing the public health.”
As evidence, Gottlieb points to a tiny catheter approved and used in Europe to replace a deteriorated aortic in lieu of the open-heart surgery so common in the U.S.
More than 15,000 patients worldwide will receive the device by the time it's slated for approval in the U.S., says Gottlieb. "Some Americans healthy enough to fly have sought the procedure in Europe," he says. "Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years."
In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end-more than four years after it first hit the market in Europe.
American device makers are moving their business overseas, says Gottlieb. Manufacturing is also moving overseas as a consequence.
Many emerging-market countries including China, India and Brazil have enacted "country of origin" rules, which require a marketed device to be made in the same country where it received regulatory approval.
“Companies know they'll get European approval long before they get the FDA's nod,” says Gottlieb. “So if they want to market their devices in these emerging markets, they need to make sure manufacturing facilities are also located in the European Union.”
Not surprisingly, U.S. investment in medical devices is falling.
According to data from PricewaterhouseCoopers and the National Venture Capital Association, the number of newly started, venture-backed medical-device companies fell to 60 in 2010 from 118 in 2008.
American Medical News reports that prescription drug shortages are increasing faster than federal health officials and drug companies can address them, and that fewer than 10 percent of drug shortages are due to a shortage of raw materials.
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