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FDA scientists say their agency is corrupt and broken
January 21st, 2009 by Kurt Niland
A group of scientists at the Food and Drug Administration has sent a letter to President-elect Obama and his transition team, urging a clean-up of the government agency. The letter says that widespread mismanagement and incompetence in the agency have “placed the American public at risk.”
The six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal.
“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,” the letter states. Because of the corrupt conditions, the scientists say that the agency is “fundamentally broken” and as such is “failing to fulfill its mission.”
The scientists who penned the letter all work in the Center for Devices and Radiological Health,” a division of the FDA that “regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines,” according to a report by CNN.
“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” according to the letter, which was addressed to President-elect Obama’s transition team leader, John Podesta.
The complaints of the scientists in the Devices and Radiological division iterate many of the same grievances raised by scientists from the FDA’s drug review division when Merck’s painkiller Vioxx came under fire in 2004.
“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the letter states. “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.”
Occasionally, scientists and doctors examining medical devices and equipment have been told during the approval process to ignore FDA regulations. The letter also charges that managers lacking the right level of knowledge and experience are authorized to push products through the approval process while ignoring concerns about safety and efficacy.
Top FDA managers “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,” the letter said.
The letter also charges that devices entering the market have been improperly labeled, and that manufacturers have been allowed to market their products without the FDA’s approval.
Internal investigations of these charges has amounted to “absolutely nothing,” according to the scientists. “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 response to the accusations, FDA spokeswoman Judy Leon said “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.”
