FDA Scientists Complain to Obama about Corruption at FDA

A group of FDA scientists have written a blunt letter to President-elect Obama’s transition team about corruption and mismanagement at the federal agency’s medical device inspection division. The letter was written on Center for Devices and Radiological Health letterhead. The division is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. Interestingly, the concerns outlined in the letter are similar to those voiced by members of the FDA’s drug review division during the Vioxx investigation.
The letter, released to the Associated Press by a Congressional official, states, “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “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.”
With the Supreme Court’s ruling concerning pre-emption in Riegel v. Medtronic, this letter’s importance can not be overvalued. Congress will be considering a measure to overturn the Court’s decision and given the reports of problems with the FDA, the legislation appears to have a good chance at passing.