News | March 31, 2010

FDA Cleared of Criminal Actions With Medical Device Approval

Ralph Tyler is the FDA's chief counsel.

March 31, 2010 - Federal investigators found no evidence supporting charges by several doctors and scientists working for the U.S. Food and Drug Administration (FDA) that managers retaliated against them for not approving certain medical devices.

The employees also alleged managers "ordered, intimidated and coerced" the scientists to manipulate data during product reviews, particularly within the Center for Devices and Radiological Health (CDRH). They also said approvals were not documented appropriately, and that decisions were influenced by the industry or politicians.

In 2008 and 2009, a group of FDA doctors and scientists wrote to Congress complaining their jobs were affected after they had raised their concerns. They spoke publicly about overuse of radiological devices in treatment and testing, and said that use of some imaging machines poses the possibility of dangerously high doses of radiation for patients.

In a letter sent in October of 2008 to the House Energy and Commerce Committee Under, the whistleblowers said "managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions, that are not scientifically proven and clinically validated."

A report issued on January 15, 2009 by the Government Accountability Office (GAO), the investigative arm of Congress responsible for enhancing the performance of all federal government agencies, concludes that the FDA has approved many medical devices that have never been shown to be safe or effective. The GAO report advises that immediate steps be taken to modify the review policy for medical devices defined as "higher risk."

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