Probe on FDA medical device approval gets tough. A letter from scientists and physicians at the Food & Drug Administration (FDA) has charged that the agency has corrupted the process by which new medical devices are approved, Bloomberg.com reports. The letter was sent to Democratic Representative John Dingell, Chairman of the House Energy and Commerce Committee, and has prompted the committee to launch an investigation into the matter.
The names of scientists who wrote the letter, as well as the devices to which they refer, have been redacted in the copy of the correspondence released to the public. But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”
Managers at CDRH have “ordered, intimidated and coerced FDA experts to modify their scientific reviews
The letter charges that managers at CDRH have “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.
Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.”
In a statement reacting to letter, Dingell and fellow Michigan Democrat, Rep. Bart Stupak, said that they have launched an investigation into the charges. “These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of America consumers,” Dingell said in the statement.
“I commend the FDA scientists for courageously sounding the alarm on what appears to be a serious problem. I look forward to pursuing the steps necessary to ensure that the medical devices Americans depend on are safe and effective.”
According to the statement, Dingell and Stupak have sent a letter to FDA Commissioner Andrew von Eschenbach requesting a briefing on what has been done to address the charges made by the agency’s scientists and physicians, as well as what the Commissioner intends to do in the future resolve all issues raised by the letter.