FDA Scientists Allege Coercion In Medical Device Approval Process, House Panel Investigates

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Nov 2008 - 5:00 PDT

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The House Energy and Commerce Committee on Monday launched an investigation into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns, CongressDaily reports (Edney, CongressDaily, 11/18). Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) said that the investigation was prompted by an Oct. 14 letter "written on behalf of a large group of Center for Devices and Radiological Health scientists and physicians who state that CDRH managers have 'corrupted and interfered with the scientific review of medical devices'" (Reichard, CQ HealthBeat, 11/17). The letter to the committee, released publicly on Monday, did not include the names of the FDA scientists or information on which device approvals the scientists questioned (Harris, New York Times, 11/18).

The scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants. "This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation," the scientists wrote (CongressDaily, 11/18).

The scientists first expressed these concerns in a letter sent to FDA Commissioner Andrew von Eschenbach in May. Von Eschenbach instructed William McConagha, the agency's assistant commissioner for integrity and accountability, to investigate the matter further (New York Times, 11/18). McConagha found the evidence provided by the scientists "'sufficient' to justify curative and disciplinary actions," according to the October letter. The scientists wrote, "The director of CDRH then conducted his own investigation and concluded that we, FDA physicians and scientists, need to 'move forward,' thus allowing managers to avoid and evade any accountability."

Stupak said that the committee "intends to learn what action FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities" (CQ HealthBeat, 11/17). Dingell and Stupak in a letter sent to von Eschenbach on Monday wrote that "our preliminary witness interviews and document review confirm that sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists."

According to CongressDaily, "Potential changes to FDA's medical device review process that could stem from the investigation could be addressed next year when Dingell and Stupak plan to propose legislation they have released in draft form to help the agency better police products" (CongressDaily, 11/18). In the letter, the scientists asked Congress to consider overhauling FDA's review process that allows approval of medical devices that have not been fully proven effective (New York Times, 11/18).

Opinion Piece
"One of the most important of the Obama administration's political appointees will be the head of" FDA, as the agency "is desperately in need of renewal," Henry Miller, former head of FDA's Office of Biotechnology Products and a fellow at Stanford University's Hoover Institution and the Competitive Enterprise Institute, writes in a Washington Times opinion piece. Miller writes that because FDA is "dysfunctional, suffering from cultural, organizational and management problems that have been exacerbated by congressional mandates and meddling," the nominee will need "[s]uperior management skills and experience"; "[u]nassailable integrity and honesty"; "[d]istance from politics"; and be "[c]ommitted to regulatory reform." According to Miller, "These are stringent, but not impossible, qualifications," and by appointing a commissioner with these qualities, "the Obama administration can demonstrate that it puts patients' needs first and that 'change' is more than a hollow campaign slogan" (Miller, Washington Times, 11/18).

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