Monday, May 7, 2012

Survey Of FDA Workers Reveals Concerns About Corporate Interests In Device Approval Process

Survey Of FDA Workers Reveals Concerns About Corporate Interests In Device Approval Process:

"Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports on the results of a 2011 survey conducted by the Union of Concerned Scientists ("UCS") that showed that workers in the U.S. Food and Drug Administration's ("FDA") medical device approval section were concerned about the influence of special interests on device approval decisions.* The study, released on March 7, 2012, revealed that some workers felt pressured to approve devices even when they harbored doubts about the devices' safety. One in four of the participants answered yes to the question: "Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?" This is especially alarming given the recent attention surrounding the FDA 510(k) device approval process, which allowed allegedly dangerous devices such as vaginal surgical mesh and certain metal hip implants to be marketed without clinical testing."

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