Tuesday, January 13, 2009

Times Says Shays Intervened to get FDA Approval for Constituent's Device

The New York Times reports an FDA official "overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from" Rep. Christopher Shays, "according to internal agency documents." His "call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency's office of device evaluation." Documents obtained by the New York Times show "that front-line agency scientists, like many outside critics of the agency, believe that FDA managers have become too lenient with the industry." According to the documents Shays called to "express concern about the fate of a computer device" made by Fujifilm Medical Systems in Shays' district.

No comments: