More Reports of Approval Pressure at FDAMore Reports of Approval Pressure at FDA
A call from a legislator may have prompted FDA officials to override scientists and approve the sale of an imaging device for breast cancer according to agency documents, reports the New York Times.
January 14, 2009
This is the latest is a long line of allegations by FDA scientists who feel officials are shepherding medical devices through approval regardless of scientific evidence for efficacy.The House Committee on Energy and Commerce has begun its investigation, thereby making documents such as e-mails that highlighted the phone call public.In the documents, the Times reports that former representative Christopher Shays, (RâEUR"CT) is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that helps radiologists detect breast tumors. The device in question was the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, used with screening equipment from Fujifilm Medical Systems.Mr. Shays told the paper that he called the agency supervisor only to demand that it make a final decision, not that it approve the product. Fujifilm Medical spokesperson, Courtney Kraemer, said the company had called its âEURoelocal Congressional offices to ask them to help us get clarification on the FDA process.âEURAlthough its really FDA that is in the hot seat, industry should prepare itself. We should expect more such allegations, and without the cushion of redaction to protect the names.
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