surprise inspection: FDA

This publication has been very critical of the FDA in recent months. Under the Bush Administration, the organization has seemed to lean towards corporate well-being instead of patient well-being; allowing drugs, chemicals, and equipment to get approval without sound research. Bisphenol-A seems to be the leading example of such activity.

Well, we seem to not be the only ones. A group of scientists at the U.S. Food and Drug Administration sent a letter to President-elect Barack Obama’s transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law, according to the Wall Street Journal.

Indicating that the organization is “fundamentally broken”, the scientists main concern centered around the review process for medical devices. The critics contend that it has been “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”

The group also says that they have taken their concerns to the head of the FDA, Andrew von Eschenbach, as well as the Commissioner in Charge of Accountability and Integrity, Bill McConagha. The response has been less than positive as either nothing has been done or the problematic managers have been rewarded and promoted.

Much of this will have to be addressed to Tom Daschle, who is Obama’s appointment for the Department of Health and Human Services. It will be his responsibility to investigate the charges and make changes, appropriately.

We have reported in the past about the FDA’s failings with the approval of Bisphenol-A. The chemical was approved after only two multi-phase studies, which would be considered unacceptable, normally. There is even evidence that the chemical manufacturers, such as Dow, was allowed to write the safety and efficacy reports.

Since the approval, repeated studies have shown this to be a much more dangerous chemical than expected. Doing most of its harm because it acts as a hormone mimicker it seen as the cause of cancers, sterility and genital deformities. The chemical is used as a synthesizing agent during the process of plastics and other metals (such as soda cans). And, unfortunately, is found at high levels in products targeted towards children (bottles, toys, and drinks) making exposure to the the toxin abnormally high.

It will be very interesting to see how the Obama Administration follows up with FDA and the changes implemented.