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FDA Commissioner Andrew von

FDA Approved Medical Devices Without Scientific Review

January 19, 2009 05:34 PM
by Sarah Amandolare
An investigation revealed that certain approved medical devices had not been fully reviewed by the FDA, dealing the organization another blow and reinforcing scientists’ request for Obama to fix it.

Bad Week for FDA

The Los Angeles Times reports that various medical devices, including “certain hip joints” and “a type of defibrillator,” gained approval from the Food and Drug Administration without first going through “a close, scientific review,” according to a congressional investigation.

This issue was supposed to have been resolved “years ago.” But the FDA has not followed through, resulting in device recalls because of “malfunctions and other problems,” the consumer group Public Citizen told the Los Angeles Times.

The investigation comes on the heels of a separate FDA-related matter. Last week, nine FDA scientists wrote a letter to President-elect Barack Obama requesting that he fix the “broken” organization. The scientists also claimed that some products are sold without FDA approval.

The Los Angeles Times asserts that, taken with the letter, the results of the investigation “probably will raise the level of congressional scrutiny over the FDA’s medical devices branch.”

“It all adds up to less-than-rigorous device review, and it’s placing tens of thousands of Americans at risk,” Peter Lurie, deputy director of Public Citizen’s health research group, told the Los Angeles Times.

Background: The FDA and food safety

The Grocery Manufacturers Association is urging the President-elect to devote more spending to food safety, while cutting corn-based ethanol subsidies, according to Reuters. The group has asked Obama to put $900 million toward “food-related spending” by 2012, claiming that the FDA has lost scientists and inspectors due to lack of funding.

Related Topic: More FDA turmoil expected

In December, FDA commissioner Dr. Andrew C. von Eschenbach said he planned to resign on Inauguration Day, one of many “expected departures at the nation’s crucial public health agencies,” according to The New York Times. Transitions at the FDA are predicted to be the “most difficult” out of all of the nation’s health agencies.

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