GAO Says FDA Must Take Immediate Action on Medical Devices

The Government Accountability Office has issued a report saying the U.S. Food and Drug Administration needs to take immediate action to make sure high-risk medical devices go through the appropriate approval process.
 
This comes on the heels of federal scientists complaining to President-elect Barack Obama’s transition team in a letter of widespread managerial misconduct within the FDA. They also sent a similar letter to Congress.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday.

The concerns of the nine scientists who wrote to the transition team repeat some of the complaints from the FDA’s drug review division a few years ago during safety concerns over painkiller Vioxx.

The FDA said it is working to address the concerns.

In their letter, FDA dissidents claimed that agency managers use intimidation to eliminate scientific debate, leading to the approval of medical devices whose effectiveness and safety are questionable.
 
“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices … have ignored serious safety and effectiveness concerns of FDA experts,” the letter said.
 
In the letter, the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that resulted in unnecessary breast biopsies.
 
Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Still, FDA managers overruled the objections and ordered approval.

Senior Democratic and Republican lawmakers are encouraging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts.
 
Industry officials fear, however, that approval of new drugs and devices could be delayed by endless scientific disputes within the agency.
 
The Obama transition team did not return repeated requests for comment.