December 15, 2008
FDA staff: experts were manipulated
Staff physicians and scientists described by congressional investigators as “a large group” in the FDA's medical device center have complained to commissioner Andrew von Eschenbach that their attempts to use sound science in evaluating medical devices have been thwarted by non-scientific center managers and executives.
Echoing similar anonymous complaints made earlier by counterparts in the agency's human and animal drug centers, they also charge there have been reprisals for their complaints to the commissioner. The physicians and scientists have now taken their case to House Energy and Commerce Committee, which has started its own investigation.
In an anonymous letter to the committee, the dissidents say their managers have “failed to follow the laws, rules, regulations and agency guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices.” They say they have amassed significant documentary evidence that device center managers have corrupted and interfered with the scientific review of medical devices.
And to avoid accountability, these same managers 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.”
“These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of American consumers,” House Energy and Commerce then-chairman John D. Dingell said in announcing the congressional investigation.