Scientists and doctors with the FDA have sent a strongly worded letter to President Barack Obama calling for "sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long."

Excerpt of letter send by FDA staff.

The letter, released in conjunction with a Senate finance committee hearing over Kansas Gov. Kathleen Sebelius' nomination to be secretary of the U.S. Department of Health and Human Services, cites a number of times in which FDA officials rejected the opinions of the scientific staff.

It also details a culture in which the staff feared retaliation for speaking out to the media and to Congress. The letter notes that several FDA officials it says were guilty of wrongdoing have recently left the agency but "the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place."

The FDA employees advise the president to take action:

The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA's jurisdiction and may need referral to the U.S. Attorney General.

Update

There have been some questions about why the names of the FDA scientists have been blacked out on these letters. Grassley explains in his statement that he did this to protect them from retaliation:

These letters are from a group of nine scientists at the FDA. They are writing for a second time to President Obama today regarding their grave concerns about the FDA. Governor Sebelius, I want to be sure that you aware of these concerns from whistleblowers inside the agency. I also want to note that I am providing copies for the record that do not identify the whistleblowers by name. They are afraid of retaliation particularly in light of the former acting FDA Commissioner's recent statements and the President's recent signing statement that seems to limit whistleblower protections.

By: Pia Christensen
Healthjournalism.org
April 2, 2009
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