FDA Document Leak Reveals Agency “Spies” on Employees The Wall Street Journal reported

FDA Document Leak Reveals Agency “Spies” on Employees
The Wall Street Journal reported in mid-July that there was an “accidental disclosure of confidential government files,” including material from the National Health Institute (NIH) and the U.S. Food and Drug Administration (FDA). The leak came from documents-handler Quality Associates, which had been hired by the FDA to handle documents related to a litigation. Quality Associates’ relationship to the NIH is not immediately clear.

An array of documents, emails and correspondences were found available online showing that the FDA was monitoring employees it found to be dissident. The documents allegedly showed that the FDA would retaliate against employees who reported or expressed concerns to the U.S. Congress about drugs or medical devices approved by the agency.

One of the former FDA employees affected by this controversy is Robert C. Smith, M.D., a radiologist and lawyer who used to work for the agency but was placed on administrative leave in 2010. Expressing to management that the FDA was not, in his opinion, “following the law, not following the science, [and] not following FDA core values,” he was placed on leave in July 2010—three months after the surveillance of employee emails began.

In April, the FDA began monitoring the computers of five of its scientists, including Smith, to determine if they were responsible for leaking confidential documents submitted to the agency by medical device firms. The monitoring also uncovered emails between the scientists and congressional staffers and the U.S. Office of Special Counsel, which represents whistle-blowers at federal departments.

Sen. Chuck Grassley (R-Iowa) began an investigation into allegations of the FDA spying on its employees in January this year, in response to the whistleblower allegations. In early June, Grassley indicated he had been promised a response from the FDA repeatedly with no follow through:
“After four months of pushing on our end, at last, the FDA commissioner herself indicated that an FDA response was on the way,” he said. “Then the FDA abruptly switched gears and said an unnamed official in the administration is reviewing the response. That leaves the response in limbo. The FDA staff wouldn’t give any more details. This puts us back to square one, and it’s not a good development from an administration that was supposed to be the most transparent in history.”

Finally, on July 13, the senator received a letter response from the FDA Assistant Commissioner for Legislation Jeanne Ireland. The letter noted that the FDA “shared his concern” for the privacy of employees and the preservation of their right to raise concerns with internal procedures and approved technologies; then she goes on to say, “At the same time, FDA has important obligations to ensure the integrity of the medical device premarket review process, which requires FDA, including the Center for Devices and Radiological Health, to routinely receive and review trade secrets and confidential commercial information submitted by regulated entities, the disclosure of which could cause competitive harm to the company submitting the information.”

According to Grassley, the private FDA documents refer to whistleblowers as “collaborators,” congressional staff as “ancillary actors,” and newspaper reporters as “media outlet actors.” The documents, Grassley also says, “explicitly authorized, in writing” the agency spying on employees.

Grassley sent a letter to FDA Commissioner Margaret A. Hamburg on July 16 expressing his disapproval of the way the agency has responded to the leak. Grassley also has a letter out to Quality Associates, asking the company how the documents were leaked and what other agencies the company manages documents for.

In his letter to Hamburg, Grassley said it was “simply not credible” that the agency “cannot identify who authorized the spying.” An FDA spokeswoman confirmed that the agency was looking into that question.

Smith now has a private radiology practice in Great Neck, N.Y. He told the New York Times in an interview, “I’m not the kind of guy who ever in his life turns a blind eye to things,” standing by his claims that the FDA is a corrupt organization.

The FDA is now under investigation by Kathleen Sibelius, secretary of the U.S. Department of Health and Human Services.