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FDA Scanner Approval Process Reinvestigated

October 1, 2010
Written by: , Filed in: Practice Management
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Federal inspectors are reopening an investigation into allegations that Food and Drug Administration managers pressured scientists to approve scanners despite the scientists’ concerns about patients’ radiation exposure.

The Department of Health and Human Services (HHS) inspector general’s office closed the case in February, saying it found “no violation of law.” FDA scientists-turned-whistleblowers say that’s beside the point because they complained of mismanagement and violations of regulations, not violations of law.

“The original intent of the investigation was to look at criminal matters, and our agents did that,” Gerald Roy, deputy inspector general for investigations at HHS, told The Associated Press. “But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective.”

The initial AP report earlier this week seemed a little shaky on medical knowledge. It said: “At issue are CT scanners, MRI machines and other medical devices that use radiation to detect or treat disease.” A Wall Street Journal article also included MRI machines among devices that “may expose patients to radiation.”

At any rate, many of the accusations involve the FDA’s 510 (k) approval process for medical devices. It’s a simplified system that’s supposed to be reserved for devices that are substantially equivalent to something that’s already on the market. Manufacturers have pushed the agency to expedite such reviews.

Some of the internal FDA disputes have revolved around whether a device really does exhibit “substantial equivalence” to a current product. Others involved managers setting aside concerns of staff scientists and even trying to coerce scientists into dropping their objections.

One scientist opposed approving a CT scanner for routine colon cancer screening out of concern about exposing healthy patients to radiation, according to the AP story. “He says he was ridiculed by agency managers for ‘raising the bugaboo of radiation,'” the story said. In addition, the AP said:

The whistleblowers also point out that FDA managers are evaluated, in part, on their ability to get speedy reviews of devices, causing them to pressure and sometimes overrule scientists who slow down the process.

The FDA so far has declined to comment.

Related seminar: Radiology Review

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