That’s what many consumer advocate groups are hoping for after reading the latest report from the Government Accountability Office (GAO) and letters by the U.S. Food & Drug Administration’s (FDA’s) own scientists who say that the current FDA system is badly broken.

The GAO report

The GAO report says that the FDA needs to take immediate steps to ensure that high risk medical devices go through the FDA’s lengthy pre-market approval process instead of just being cleared – which is how many devices currently end up on the market. While the GAO report mirrors what many others have been saying for the past few years, several consumer advocate groups hope that this report, as well as damaging letters from the FDA’s own scientists, will prompt President Obama’s administration to clean house.

Letters to FDA Commissioner & President Obama

While the GAO report is certainly damaging to the FDA’s already tainted reputation, nothing could be more damaging then letters from the FDA’s own scientific team alleging that they are, and have been, forced to alter scientific data regarding the safety of medical devices that are used by consumers on a daily basis.

The first letter was sent to the FDA Commissioner in November 2008 and the second to President Obama’s transition team in January 2009. According to CNN, the letters allege that:

• Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.
• Devices have not been properly labeled.
• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.
• FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."
• Manufacturers have been allowed to market their products without FDA approval.

To view a news report from CNN on the issue, please click here.