Bad Blood at the FDA

A decade's worth of trouble continues at the Food and Drug Administration. When Bush II's people came in, they believed that scientists at the FDA were too hostile toward drug and instrument companies, leading to years of unnecessary delays in the approval of vital drugs and techniques.They tried to make the FDA's procedures less adversarial and more cooperative. They also slashed the FDA's budget for doing its own studies, leaving it completely dependent on studies done by the manufacturers. This reform was done in a way that bitterly alienated the FDA's scientists and created a terrible rift in the organization. Dozens of key people retired, and many were not replaced. Several people I know spoke of the agency being "destroyed." For the last decade the FDA has replaced the Library of Congress as the federal agency with the worst relations between its managers and staff.

Now the latest chapter has made the NY Times, where Eric Lichtblau and Scott Shane report that the agency's managers have been spying on scientists they deem unreliable:

A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show. . . .

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

The scientists have sued the agency, and they are likely to win. Communications between Federal employees and Congress are protected by law, and these men were pursuing a formal grievance against their managers, which made any emails pertaining to that case confidential as well. More important, no organization can function with this level of mistrust, and that means the FDA is not protecting the citizens in the way it is supposed. Obama's people have let this slide for too long, and he needs to send somebody to clean this mess up.