Sunday, January 11, 2009

FDA Scientists Complain to Obama About Managerial Misconduct

Here is something worth watching: News from the FDA's scientists. A group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the FDA.

"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, written on the agency's Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"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.

Why does this matter? Because all is not as it seems when it comes to medical device approval it now seems. So, when a Court considers the FDA's preamble in knocking out potentially legitimate injury claims, it shows that the very foundation of a drug's approval is shaky, IMO. It's not a clean system, and obviously protectionist legislation solved nothing.

More here.