An FDA probe of 5 dissident scientists from its medical device review arm may have broken the law when it resulted in the inadvertent public disclosure of confidential information.
The federal watchdog agency’s Center for Devices & Radiological Health began investigating the scientists after medical device companies complained that confidential data was being leaked to the media. After President Barack Obama’s election and the appointment of new leadership at the agency, including CDRH chief Dr. Jeffrey Shuren, the medical device arm installed software on the scientists’ computers to record their activity, down to the last keystroke, the New York Times reported.
But when the time came to answer discovery requests in a lawsuit filed by some of the scientists over the surveillance, an outside contractor hired to produce the documents accidentally made them available on the Internet for “at least several days as recently as May,” according to the Wall Street Journal.
The FDA’s device review system got a lot of unwanted attention in the fall of 2010 after a handful of scientists complained that the agency pressured them to approve medical devices despite their own reservations about the health risks. In an open letter to Obama, the scientists called for "sweeping measures" to end "the systemic corruption and wrongdoing that permeates all levels of the FDA." The proceeding hubbub led the U.S. Dept. Of Health & Human Services’ Office of the Inspector General to dig deeper into the CDRH’s management of scientific disagreements.
Earlier this year, six of the so-called "FDA 9" whistleblowers sued the agency, alleging that it violated their constitutional rights with surveillance of their private email accounts. The lawsuit accuses the agency of using the information gleaned from the tapped email accounts to harass and, in some cases, fire the whistleblowers.
But the actual extent of the surveillance was unknown until the outside contractor’s goof, according to the Times. The FDA created a de-facto enemies list of 21 perceived opponents, the newspaper reported, and monitored private emails the scientists sent to members of Congress and even Obama.
"Moving to quell what 1 memorandum called the ‘collaboration’ of the FDA’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 Times reported.
"FDA officials defended the surveillance operation, saying that the computer monitoring was limited to the 5 scientists suspected of leaking confidential information about the safety and design of medical devices," according to the report, but the agency admitted that the scientists’ emails "were collected without regard to the identity of the individuals with whom the user may have been corresponding" – including some of the email traffic to journalists, lawyers, legislators and the president.
The surveillance alone may be enough to violate attorney-client privilege and laws designed to protect whistleblowers who act in the interest of public health, but the release of the confidential company data is a definite breach of the FDA’s own requirements to protect such information.
Ironically, the agency’s probe was aimed at fulfilling that mandate, spurred by an Oct. 2010 article in the Times airing concerns about radiation exposure from imaging devices. Lawyers for GE Healthcare (NYSE:GE) allege that the article divulged trade secrets that "may have been improperly leaked by FDA employees," according to the Times. That spurred FDA officials to ask the OIG to investigate whether any crimes were committed with the leaks and to seek a criminal investigation. But after the OIG found no evidence that any crimes were committed, the officials went ahead with the surveillance program, the newspaper reported.
"Although some senior FDA officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation," according to the Times.