Democrats probe 'corrupted' reviews of devices at FDA

This is an archived article that was published on in 2008, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Posted: 2:47 PM- Top managers with the U.S. Food and Drug Administration "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 Representatives John Dingell, the panel's chairman, and Bart Stupak, a member, in a statement Monday.

The FDA has repeatedly 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. Now, agency employees 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 the FDA, in the statement.

The lawmakers, who are both Michigan Democrats, declined to disclose the names of devices that were identified by scientists. The 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 Monday in a letter to Andrew von Eschenbach, the FDA commissioner.

Siobhan DeLancey, an FDA spokeswoman, said she was looking into the matter and had no immediate comment.

Unsound methods

The agency employees said in their letter to Dingell, dated Oct. 14, that they were ordered by managers to make determinations about safety and effectiveness using unsound evaluation methods, and to accept data that isn't scientifically valid.

Dingell and Stupak released a copy of the employees' letter with names and other details blacked out. The scientists didn't want their names disclosed, the lawmakers said.

The scientists said they reported their concerns to von Eschenbach in May. While the agency's assistant commissioner for integrity and accountability, William McConagha, found "convincing" evidence to support the allegations, no action has been taken, according to Dingell and Stupak.

McConagha also may have recommended the removal of certain managers, the lawmakers said.

'Management reprisals'

The head of the FDA's device division conducted his own investigation and concluded that the scientists need to "'move forward,' thus allowing managers to avoid and evade any accountability," according to the letter from the scientists to Dingell. The division director "has further aggravated the situation by knowingly allowing a continuation of management reprisals," according to the letter.

While managers can disagree with FDA scientists, they are not allowed to order or coerce scientists to change their findings, according to the letter to Dingell.

One of the scientists resigned last week, saying von Eschenbach failed to take action against "corruption, illegality, gross mismanagement and retaliation at the hands of FDA managers," according to a letter to the FDA chief. The lawmakers released the letter with the scientist's name expunged.

Mark Berger, a spokesman for the Advanced Medical Technology Association, a medical-device industry group in Washington, said he couldn't comment until he had a chance to review the lawmakers' statement.