FDA Internal Documents Show Scientists' Concern About Agency's Approval Process For Medical Devices, New York Times Reports

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Breast Cancer
Article Date: 14 Jan 2009 - 4:00 PDT

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Some FDA scientists have criticized the agency's approval process for medical devices, saying that many of the products receive approval without undergoing significant scientific testing, according to internal agency documents, the New York Times reports. The Times obtained the documents, including e-mails and other memorandums, which are being used as part of an ongoing internal agency probe into complaints from nine agency scientists about device approval methods and other issues at FDA's Office of Device Evaluation.

In 2007, 41 medical devices underwent the most rigorous approval process, compared with 3,052 other devices that only received abbreviated reviews, the Times reports. According to the Times, an internal memo noted that FDA managers pushed agency reviewers to use the abbreviated process on complex or novel medical devices that likely should have been reviewed more extensively.

In November 2008, the House Energy and Commerce Committee launched an investigation after the panel received a letter from the same group of scientists. Last week, the nine scientists wrote a similar letter to President-elect Barack Obama's transition team.

William McConagha, FDA assistant commissioner for integrity and accountability, said he continues to investigate the scientists' concerns, adding that FDA Commissioner Andrew von Eschenbach has offered to meet with the scientists before Friday, his last day as commissioner.

Approval of Breast-Tumor Detection Device
According to the Times' analysis, an e-mail correspondence and related documents show that one agency supervisor disregarded scientists and approved a computer-aided breast tumor-detection device for radiologists. The supervisor approved the device -- the iCAD SecondLook Digital Computer-Aided Detection System for Mammography -- after receiving a call from former Rep. Christopher Shays (R-Conn.). The Times reports that the device is manufactured by Fujifilm Medical Systems, which is based in Stanford, Conn., Shays' former district. Shays said he called the FDA supervisor to express his concerns about the delay in the approval of the iCAD device.

Scientists said that "iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use," adding, "This is the most basic and fundamental requirement of all FDA submissions." An agency review of the iCAD device said that the risks of the device include missed cancers, "unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation." Ken Ferry, iCAD CEO, said, "We have done all the appropriate testing to get the product approved."

According to the Times, Shays rejected suggestions in the internal documents that his conversation with the supervisor played a role in the device's approval. In an interview with the Times, Shays said it "would be idiotic for someone to approve something they don't think should be approved." Courtney Kraemer, a spokesperson for Fujifilm Medical, said the company had called its "local congressional offices to ask them to help us get clarification on the FDA process" (Harris, New York Times, 1/13).

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