NEWS - FDA scientists allege mismanagement at agency

[Guest guest]

09 Jan 2009

FDA scientists allege mismanagement at agency

WASHINGTON (CNN) -- Nine scientists at the Food and Drug

Administration have written a letter to President-elect Barack Obama

and his transition team, alleging gross mismanagement at the agency

that has " placed the American public at risk. "

FDA scientists wrote a letter to President-elect Barack Obama, saying

the agency is " fundamentally broken. "

The agency is " fundamentally broken " and " failing to fulfill its

mission, " according to a copy of the six-page letter obtained by CNN.

The scientists work in the FDA's Center for Devices and Radiological

Health, which regulates items ranging from rubber gloves and contact

lenses to heart stents and mammogram machines.

The scientists claim that " the scientific review process for medical

devices at FDA has been corrupted and distorted by current FDA

managers, thereby placing the American people at risk. " Watch the FDA

come under fire »

" Currently, there is an atmosphere at FDA in which the honest employee

fears the dishonest employee, and not the other way around, " the

letter said. " Disturbingly, the atmosphere does not yet exist at FDA

where honest employees committed to integrity and the FDA mission can

act without fear of reprisal. "

Among the charges:

• 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.

An internal investigation of the charges, the scientists said, has

resulted " in absolutely nothing: No one was held accountable, no

appropriate or effective actions have been taken, and the same

managers who engaged in the wrongdoing remain in place and have been

rewarded and promoted. "

In a statement, the Food and Drug Administration told CNN, " We have

been working very closely with members of the transition team and any

concerns or questions they have on any issue, we will address directly

with the team. Separately, the agency is actively engaged in a process

to explore the staff members' concerns and take appropriate action. "

Congress is also looking into the allegations.

http://www.cnn.com/2009/POLITICS/01/09/fda.scientists/

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