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Delays in Approval Send Device Makers to Foreign Markets.
Interesting article in the New York Times. Excerpts below

Medical Treatment, Out of Reach
The New York Times
By ANDREW POLLACK
Published: February 9, 2011

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.
...
The F.D.A., they and others say, appears to be reacting to criticism that its approvals for some products had been lax, leading to a spate of recalls of some unsafe medical devices, like implanted defibrillators and hip replacements.
...
Now, executives of device companies say the F.D.A. has gone too far in flexing its regulatory muscle, and they worry that a slower, tougher approval process in a weakened economy could chill investments and cripple innovation.

Acknowledging industry concerns, the F.D.A. on Tuesday proposed creating an “innovation pathway” aimed at speeding regulatory reviews of a small number of groundbreaking devices. And last month the agency announced measures it said would make the regulatory process more predictable for the vast majority of devices.
“A consistent and predictable review process will stimulate investment here at home and keep jobs from going overseas,” Dr. Jeffery Shuren, the director of the agency’s medical device division, told reporters.

But Dr. Shuren said the F.D.A. would not relax its standards, arguing that Europe’s system might be too lax. He said that a breast implant, a lung sealant and an implant for elbow fractures were approved in Europe but not in the United States, and then had to be taken off the market in Europe for safety reasons.

“We don’t use our people as guinea pigs in the U.S.,” he said
....
Pharmaceutical executives are also complaining about how tough the F.D.A. has become. But they are not forsaking the American market, in part because there is not a big disparity in the regulatory system for drugs between the United States and Europe.

Some figures bear out a toughening in devices. The F.D.A. last year granted 19 premarket approvals — the type of clearance required for the most highly regulated devices — down from 48 in 2000.

The average time to win an approval through the less stringent 510(k) pathway, which is used for most devices, rose to 116 days in fiscal year 2008 from 97 days in fiscal year 2002. Agency figures show there have been increases in the proportion of applications sent back for questioning.

Investment by American venture capitalists in the medical device sector has fallen 37 percent since 2007 to $2.3 billion last year, according to the MoneyTree survey from PwC, the National Venture Capital Association and Thomson Reuters. That is steeper than the 27 percent drop for all venture capital investing.

Last year, total venture capital investing increased 19 percent while investment in medical devices fell 9 percent.

...
The complaints are driven in part by financial pressures. Venture capitalists, because of the financial crisis and their own poor returns, have less money and need quicker returns on their investments from the companies they back.

Bigger device companies also complain about the F.D.A., but not as much as struggling start-ups. “The F.D.A. is asking for larger trials, more thoughtful trials, all in the interest of the American public,” said Dr. Stephen N. Oesterle, senior vice president for medicine and technology at Medtronic.

To be sure, the United States remains the clear world leader in medical device innovation, according to the report by PricewaterhouseCoopers. Some 32 of the 46 medical technology companies with annual sales exceeding $1 billion are based in the United States, the report said.

Still, the report said the United States’ lead was slipping.

Device companies have been seeking early approval in Europe for years because it is easier. In Europe, a device must be shown to be safe, while in the United States it must also be shown to be effective in treating a disease or condition. And European approvals are handled by third parties, not a powerful central agency like the F.D.A


http://www.nytimes.com/2011/02/10/business/10device.html?pagewanted=1&_r=1&sq=medical treatment&st=Search&scp=1