Scientists’ Complaints about FDA Device Reviews Dismissed
November 1, 2010
Portland residents scheduled for a CT scan may want to know about recent developments in a Food and Drug Administration product safety investigation. Oregon’s product liability attorneys have been watching the case closely for almost a year now.
FDA medical device review scientists have said that their opinions were improperly overruled by management and their contracts terminated when they complained to Congress and other authorities, but, for the second time, the U.S. Department of Health and Human Services has disagreed with them. According to internal memos and emails, investigations into the allegations found no material violation of rules and no evidence of retaliation in the matter. The HHS office of inspector general has closed the case.
When the first investigation found no wrongdoing last February, federal lawmakers and outside organizations requested the matter be opened again. They claimed the first investigation had been too narrowly focused and had not explored allegations that managers had not complied with federal regulations.
One of the scientists involved has similar complaints about this second investigation. He claims that the inspector general never contacted him, in spite of his claim that his contract was terminated after he had persistently opposed using a CT scanner for routine colon cancer screening. How can it be a bona fide investigation, he asked, when no one interviewed the people lodging the complaints in the first place?
The medical devices in question use radiation in the detection and treatment of a variety of diseases but, according to the reviewers, carry a higher risk of radiation overdoses. In opposing approvals, the scientists cited reports of hundred of overdoses nationwide just last year that were linked to CT scanners and similar imaging devices.
Among their allegations were claims that the scientists were often overruled by managers who failed to give and to document their reasons for doing so. Under FDA rules, the reasons must be documented. When they filed their complaint with Congress, three scientists say the agency terminated their contracts.
According to an agency official, a consultant had reviewed the structure of the FDA’s Center for Devices and Radiological Health with an eye toward improving relations between scientists and management. Among the consultant’s recommendations were revising both training opportunities and internal communications.
Source: Associated Press “Feds Dismiss Misconduct Claims at FDA Device Unit” 11/09/10