January 30, 2012
Six former employees filed suit with the U.S. District Court for the District of Columbia against the Food and Drug Administration alleging the agency monitored their personal emails warning Congress that risky medical devices had been approved, The Washington Post has reported.
The scientists and doctors claimed the information gathered on them contributed to harassment and wrongful termination by FDA, the Post reported Sunday.
All six former employees worked in the office of device evaluation and beginning in 2007 brought concerns about FDA approval of potentially ineffective medical devices to Congress, the White House, and the Health and Human Services Department’s inspector general.
FDA monitored their correspondence and twice asked the HHS inspector general to launch an investigation, stating doctors and scientists had improperly disclosed confidential business information about the devices, according to documents obtained through a Freedom of Information Act request filed by the former agency workers.
“We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, wrote in a document in June 2010.
The HHS IG declined to pursue the investigation, finding no evidence of criminal conduct both times it was requested.
The six former employees denied sharing information improperly, but still did not have their contracts renewed, suffered harassment or were fired.
An FDA spokewoman told the Post the agency does not comment on litigation.
January 30, 2012