FDA whistleblowers file lawsuit

Study for Science Instructing Industry, 1898. Kenyon Cox, American (Smithsonian American Art Museum)

Six people, who were part of a review committee for the Food and Drug Administration (FDA), have filed a suit in federal court alleging that the agency retaliated against them because they tried to expose flaws in the process for approving medical cancer-screening devices.

The lawsuit filers include two licensed doctors, one M.D./Ph.D., one other scientist, an engineer, and a statistician, all of whom sat on scientific review committees for the Center for Devices and Radiological Health, which judges the efficacy of cancer-screening devices. The lawsuit alleges that senior FDA officials approved certain devices despite poor scientific reviews. The lawsuit mentions just a few devices—most prominently, one for colon cancer and one for breast cancer—but the complaints stretch to more than 10 different devices overall, says Stephen Kohn, the lead counsel for the filers and the director of the National Whistleblowers Center. Kohn added that in at least one case, officials pressured an engineer to change the warning labels on a device, removing negative language.

The complaints cover a period beginning in 2006 and the lawsuit was triggered when the individuals involved recently discovered that the FDA had used spyware to monitor them.

Senator Charles Grassley (R-IA), the senior Republican on the Senate Committee on the Judiciary, opened an investigation into the matter last week, sending a letter to FDA Commissioner Margaret Hamburg asking for more information.