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发帖数: 2823 | 1 Source:
http://www.washingtontimes.com/news/2011/apr/13/gao-renews-crit
By MATTHEW PERRONE
WASHINGTON (AP) - Government investigators say the Food and Drug
Administration is putting patients at risk by approving sensitive medical
devices such as hip joints and heart defibrillators under the same
streamlined system intended for power wheelchairs, stitches and catheters.
The Government Accountability Office told Congress Wednesday that the
approvals remain a serious issue for the government _ more than two years
after the watchdog agency first cited the problem to the FDA.
The GAO previously faulted the FDA in a 2009 for not reclassifying more than
26 types of devices so they receive more stringent reviews. Since then, the
agency has cleared 67 individual, high-risk devices through the so-called
510(k) system, which is used to clear the vast majority of devices.
Devices classified as high-risk tended to be ones that are implanted in the
body or could spell the difference between life and death.
Wednesday’s hearing comes as the FDA faces complaints from medical device
manufacturers that the speed of U.S. device reviews lag behind other
countries. At the same time, public safety advocates point to reports by GAO
and others that suggest the agency is being too lenient in clearing
critical, life-sustaining devices.
The Senate committee heard testimony from representatives of both groups.
The industry’s chief trade association, AdvaMed, has spent hundreds of
thousands of dollars lobbying against new device regulations that they say
would slow down innovation.
But Senate Aging Committee Chairman Herb Kohl, D-Wis., warned Wednesday that
swift approvals must not compromise safety.
“The drive toward getting new technologies to market shouldn’t be done at
the risk of patient safety,” Kohl said. “Faulty medical devices,
especially those implanted in the body, can have a disastrous impact on the
health of those who use them.”
The committee heard testimony from Katherine Korgaokar, a patient who had to
have her Johnson & Johnson hip implant removed because of a defect that
caused it to release metal into her body. Korgaokar told Senators that the
metals, cobalt and chromium, could damage a fetus and make it difficult for
her to have children.
“I had no idea how these metals would affect my body, and more importantly,
I didn’t know if they would impact my ability to have children,”
Korgaokar said.
For its part, the FDA pointed to its ongoing effort to overhaul the medical
device approval system, which is more than 35 years old. The agency
announced some minor changes to the program in January and is still weighing
broader reforms.
FDA’s Dr. William Maisel told Senators that the FDA will reclassify the 26
types of high-risk devices cited by GAO before the end of 2012.
“FDA evaluates thousands of medical devices annually and the vast majority
of these devices perform well and improve patient health,” stated Maisel’s
prepared testimony. He is deputy director for science in FDA’s device
center.
Medical devices include everything from tongue depressors to silicone breast
implants and pacemakers. In 1976, Congress set up a three-tiered
classification system for the devices.
Low-risk devices like crutches and hospital beds do not require FDA review.
Moderate-risk devices such as mercury thermometers and power wheel chairs
could be cleared by the speedy 510(k) method. If the FDA doesn’t object to
a manufacturer’s 510(k) application within 90 days, the device is
automatically approved for marketing.
High-risk devices such as pacemakers and heart valves have to go through
tighter scrutiny, and their manufacturers are required to provide studies
demonstrating their safety and effectiveness.
An exception was carved out for new versions of high-risk devices that were
already on the market in 1976, such as certain types of defibrillators and
orthopedic implants.
These devices could go through the faster 510(k) system if manufacturers
could show they were “substantially equivalent” to their precursors. In
1990, Congress ordered the FDA to end the practice, but it has continued
even as generations of technology have come and gone.
The report urged the FDA to promptly resolve the problem, either by carrying
out full reviews or reclassifying the devices as lower risk, if appropriate.
According to GAO, the FDA has reclassified only one group of devices since
2009, leaving 26 remaining.
Democratic lawmakers and public safety advocates have been pressing for
additional FDA powers to regulate devices, such as mandatory recall
authority and an extra device classification. Device companies and
Republican lawmakers have stressed the need to streamline device reviews to
keep the industry competitive. | h********e
发帖数: 2823 | 2 In my humble opinion, I really don't think that FDA represents public
interest, especially when the public interest is in conflict with the
corporate interest. Simply take a look at the resume of those high
level FDA officials, and you will see a pattern ;) It's almost like
Robert McNamara, the Secretary of Defense during the Vietnam War, became
the President of the World Bank after the war.. This is a very
interesting game.. and if you are not the one who plays the game, then
you are played by the game :P | s**********8
发帖数: 25265 | 3 not true. FDA is very strict and detail orientated.
【在 h********e 的大作中提到】
: In my humble opinion, I really don't think that FDA represents public
: interest, especially when the public interest is in conflict with the
: corporate interest. Simply take a look at the resume of those high
: level FDA officials, and you will see a pattern ;) It's almost like
: Robert McNamara, the Secretary of Defense during the Vietnam War, became
: the President of the World Bank after the war.. This is a very
: interesting game.. and if you are not the one who plays the game, then
: you are played by the game :P
| h********e
发帖数: 2823 | 4 In terms of its technical review, I would trust so :)
【在 s**********8 的大作中提到】
: not true. FDA is very strict and detail orientated.
| s**********8
发帖数: 25265 | 5 en.
【在 h********e 的大作中提到】
: In terms of its technical review, I would trust so :)
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