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Are Mainers Affected by Dishonesty at the FDA?

Honesty is the basis of good science. Government agencies such as the Food and Drug Administration (the “FDA”) count on good, honest science used by the government to protect the public.

In a recent letter to President-Elect Obama, several FDA scientists allege that dishonesty is prevalent at the agency and that the “scientific review process for medical devices has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.”

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”; and manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, according to the scientists, 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.”

With the transition to President-Elect Obama’s administration will come changes to the leadership of both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

According to a recent statement from the FDA, “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.”

By: Eliza Stoll for Briggs & Wholey
Copyright 2009 Briggs&Counsel

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