FDA Scientists Allege Their Managers Interfered With Review of Medical Devices

Jan 12, 2009 by

FDA Scientists Allege Their Managers Interfered With Review of Medical Devices

In general, I would like to focus more on health-promoting methods, rather than harp on the shortcomings and failures of conventional medicine and its organizations. But, at times, I also do feel the need to raise certain issues.

Late last year, an issue surfaced whereby a group of scientists from the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) Division accused their managers broke the rules in the review of medical equipment.

The scientists wrote a letter which claimed: “There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices.”

The letter also stated: “It is evident that managers at CDRH have deviated from FDA‘s mission to identify and address underlying problems with medical devices before they cause irreparable harm, and this deviation has placed the American people at risk.”

Congressman John, Dingell, who chaired the committee which received the scientists’ letter, then proceeded to charge that the FDA bureaucrats involved had “approved or cleared medical device applications in gross violation of laws and regulations…”

Isn’t this yet another frightening example of how the FDA, which is given the extremely important responsibility of protecting the American people, has gone haywire?

So who, really, is protecting Americans?

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