In a letter to Congress, 8 FDA scientists accuse senior FDA officials of “serious misconduct” in squelching their opinions and approving ineffective and potentially unsafe medical devices.
The letter was sent a month ago and made public in redacted form last week. It says the scientists can prove that FDA managers “corrupted the scientific review of medical devices” by coercing experts to alter conclusions about certain devices, according to the New York Times.
The scientists claim that top officials in the Center for Devices and Radiological Health told them they might be fired or given poor performance reviews if they did not alter their reports to hide unfavorable data and legal violations such as not obtaining informed consent from participants.
Public information on the matter does not specify which devices are being called into question.
“This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation,” according to the letter received by Congress.
The FDA scientists initially raised the matter with FDA Commissioner Andrew von Eschenbach in May. Eschenbach asked Assistant Commissioner William McConagha to investigate. The FDA scientists say McConagha concurred that the evidence was “’sufficient’ to justify curative and disciplinary actions” according to the letter received by Congress.
The matter was then referred to the CDRH Director who concluded there was no cause for disciplinary action. He told the FDA scientists to “move forward.”
Indeed they have.
“These allegations are deeply concerning,” Representative John Dingell (D-Mich) told the New York Times. The chairman of the House Committee on Energy and Commerce added, “We intend to uncover whether any FDA activity has compromised the health and safety of American consumers.”