Regulatory Focus™ > News Articles > Investigation into FDA Handling of Whistleblowers Widens

Investigation into FDA Handling of Whistleblowers Widens

Posted 16 February 2012 | By Alexander Gaffney, RAC 

The US Office of Special Counsel (OSC) announced on 15 February that it had opened an investigation into the US Food and Drug Administration's (FDA) handling of whistleblower complaints made by employees of its Center for Devices and Radiological Health (CDRH).

The new investigation adds to two already launched by members of Congress and a lawsuit filed by six of the whistleblowers in the US District Court in Washington, creating a situation that could become politically damaging for FDA.

The Office of Special Counsel Steps In

OSC-a self-described federal investigative and prosecutorial agency-said it is opening the investigation in light of "new and troubling allegations of retaliatory surveillance of OSC communications and other acts of retaliation against the whistleblowers, including FDA attempts to initiate criminal prosecution of the whistleblowers."

"Relying on documents obtained through [the Freedom of Information Act], the whistleblowers allege that the agency reviewed disclosures intended specifically for OSC, and that the agency also monitored the communications of employees who were suspected of blowing the whistle on FDA's approval of unsafe medical devices," continued OSC in a press statement.

OSC further noted that under the Whistleblower Protection Act, all communications with OSC are explicitly authorized, and such communications are meant to be confidential.

"Monitoring employee emails with OSC or Congress could dissuade employees from making important disclosures," said Special Counsel Carolyn Lerner in the press release.

Whistleblowers File Suit

Six staff scientists, former employees of CDRH's Office of Device Evaluation (ODE), first brought their concerns about the safety of some medical devices to FDA in 2007, and later to the Inspector General of the US Department of Health and Human Services (DHHS), the White House and Congress. They alleged that a number of medical devices approved or on the verge of approval by FDA were not proven to be safe or effective.

After their concerns were sent to the White House and Congress, several news agencies covered the story, which resulted in FDA placing the signatories of the letter under surveillance, according to The Washington Post.

The six of the staff scientists filed suit in the US District Court in Washington in January, while an additional three staff scientists were involved in whistleblowing but did not file suit. Their complaint alleges FDA violated their right to privacy by monitoring their personal email correspondence for "lawful" activities.

Congressional Investigations

Members of Congress have also begun to investigate the issue.

Senator Charles Grassley (R-IA) opened an investigation on 31 January into the matter, saying "It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress."

"It is troubling to me to see your Agency actively pursue the dismissal of an employee against the advice of the OSC-not because they violated procedure and leaked genuinely confidential classified information, but simply because you 'cannot trust him,'" wrote Grassley in a letter to FDA Commissioner Margaret Hamburg.

House Oversight Committee Chairman Darrell Issa (R-CA) mirrored Grassley's concerns in a letter to Commissioner Hamburg sent 9 February.

"The appearance of wrongdoing by FDA managers is heightened because the agency used the intelligence it gathered to build a case to retaliate against the FDA Nine," wrote Issa, referring to the nine FDA staff scientists.

"Additionally, federal law prohibits managers from initiating a personnel action against an employee in response to protected whistleblowing by that employee," noted Issa.

Hamburg defended the agency's actions during an interview with Forum host Michael Krasney on 6 February.

"FDA employees, when they sign on to their computers, are made aware about the possible monitoring of information," said Hamburg. "They don't have an assurance of privacy on certain types of communication." Hamburg declined to discuss the specifics of the case citing the ongoing nature of the investigation.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe