Dems Probe ‘Corrupted’ FDA Reviews of Devices

NEW YORK—Top managers with the U.S. Food and Drug Administration (FDA) “corrupted and interfered with” scientific reviews of medical devices, agency scientists said in a letter that is sparking a congressional investigation.

The House Energy and Commerce Committee will review “compelling evidence” that devices were approved in violation of laws to ensure their safety, said Reps. John Dingell, the panel’s chairman, and Bart Stupak, a member.

The FDA repeatedly has come under criticism from current and former agency scientists who have said bosses forced them to change findings critical of drugs being considered for approval. Agency employees now have sent Dingell a letter saying managers “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations” on devices, the lawmakers said in the statement.

“These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of American consumers,” said Dingell, whose committee oversees FDA.

The lawmakers, both Michigan Democrats, declined to disclose the names of devices that were identified by scientists. FDA classifies a range of products as medical devices, from pacemakers for the heart to breast implants.

Scientists who objected to the management practices “have been subject to reprisals including removal or threatened removal and illegal or inappropriate employee performance evaluations,” Dingell and Stupak said Nov. 17 in a letter to FDA Commissioner Andrew von Eschenbach.

FDA won't comment and instead will respond directly to the lawmakers, Siobhan DeLancey, agency spokeswoman, said.