Last month, a group of nine FDA scientists wrote to the Obama transition team reporting widespread managerial misconduct in a division of the Food and Drug Administration. Specifically, in a letter written on FDA Center for Devices and Radiological Health letterhead, the FDA scientists complained that agency managers use intimidation to suppress scientific debate, leading to the approval of questionable medical devices that may not be safe for the American public.

Various quotes from the letter provided to The Associated Press by a Congressional official, include:

-"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."

-"[Top FDA officials] committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

-"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts."

-"Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

-"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."

This letter continues to confirm that the FDA, whose duty is to protect the safety of the American public, is in desperate need of repair. It also reflects the power of large medical drug and device companies, who care more about profits than people, to influence the highest levels of government. We continue to support lawmakers who are seeking to overhaul the current FDA and once again restore confidence in the agency, so that catastrophic failures such as the heparin debacle will not happen again.