FDA Scientists Request Investigation Into Agency Approval Of Breast Imaging Device

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Breast Cancer;  MRI / PET / Ultrasound
Article Date: 14 Jan 2009 - 4:00 PDT

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Scientists at FDA have requested that Congress and President-elect Obama investigate their allegations that an FDA official approved the sale of a breast cancer imaging device over the objections of the front-line scientists after receiving a phone call from a Connecticut congressman, according to the New York Times. The Times reports that the call from the congressman and its "effect on what is supposed to be a science-based approval process" represent "only one of many accusations in a trove of documents" the newspaper received regarding disputes within the FDA Office of Device Evaluation.

According to the Times, the documents show through e-mail correspondence that top agency scientists allege that an agency supervisor inappropriately forced them to modify reviews of the iCAD SecondLook Digital Computer-Aided Detection System for Mammography -- a computer device to assist in the detection of breast tumors -- after former Rep. Christopher Shays (R-Conn.) called an agency supervisor a few years ago to voice concerns about the future of the device. According to the Times, the device is used with screening equipment made by Fujifilm Medical Systems, which is based in Shays' former district. According to the FDA documents, the nine scientists involved with the iCAD decision said that the company "never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all FDA submissions." The risks of iCAD include missed cancers, "unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation," according to an internal review. Courtney Kraemer, spokesperson for Fujifilm Medical, said that the company called its "local congressional offices to ask them to help us get clarification on the FDA process." Shays said that he called the FDA supervisor only to demand the agency make a final decision on the device but that he did not request that it be approved. He added that it would be "idiotic for someone to approve something they don't think should be approved."

The internal review was ordered in May 2008 after nine scientists complained to FDA Commissioner Andrew von Eschenbach, the Times reports. However, the scientists were "dissatisfied with the pace of that review," so they wrote a letter to Congress in October 2008 to request an investigation, which the House Committee on Energy and Commerce said it began in November 2008. A similar letter was written to President-elect Barack Obama's transition team last week, the Times reports. William McConaghah, FDA assistant commissioner for integrity and accountability, said that officials in the Office of the Commissioner are "extremely concerned about allegations like this" and that he is still investigating the scientists' claims.

Broader Concerns

The Times reports that a "growing chorus of critics" have expressed concern that FDA requires few devices to complete the most thorough of the agency's three-tiered review process and "instead allows most devices to be cleared with minimal oversight." The internal documents show that other FDA scientists "seem to agree with these critics," according to the Times. Forty-one devices went through the most thorough review process in 2007, compared with 3,052 that underwent abbreviated reviews. One internal memorandum made available to the Times argued that FDA managers had pushed agency reviewers to use the abbreviated process "even to approve devices that are so complex and novel that extensive clinical trials should be required," the Times reports (Harris, New York Times, 1/13).

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