A letter to President-Elect Obama from nine FDA scientists makes alarming charges of mismanagement at the FDA, alleging incompetence, intimidation, and inappropriate industry influence.
According to the letter:
- 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.
For some reason, we weren’t given a copy of this letter, but an apparently similar letter from concerned FDA employees to Congress last fall is available here (PDF).