Regulatory Focus™ > News Articles > Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

Posted 30 January 2012 | By Alexander Gaffney, RAC 

A group of former staff scientists at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) are accusing FDA of monitoring their interactions with Congressional staffers after FDA found that the staff scientists were submitting whistleblower complaints to Congress.

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 the Department of Health and Human Services (DHHS) inspector general, 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 effective or safe.

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 this week, while an additional three staff scientists were involved but did not file suit. Their complaint alleges FDA violated their right to privacy by monitoring their personal email correspondence for "lawful" activities.

The complaints are generating some pushback from Congress, including from influential Iowa Republican Charles Grassley.

"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," said Grassley in a statement this week. Grassley serves on the Senate Finance committee, which oversees many healthcare matters in the Senate.

DHHS launched an internal investigation in to the matter in 2010, and found that the scientists were not guilty of any criminal conduct and that they were allowed to divulge their concerns to congress. A second attempt to investigate the scientists, initiated by CDRH Director Jeffery Shuren after new information was reportedly discovered, was declined after DHHS conferred with federal prosecutors.

At issue, writes The Washington Post, is "the lengths to which a federal agency will go to monitor employees," and if "monitoring was legal and what level of monitoring on government computers is reasonable at a time when technology increasingly blurs the lines between work and home."

All of the staff scientists involved in writing the letter have since been let go by the agency, fired, passed over for promotion or harassed, according to statements obtained by The Washington Post.

When reached for comment by The Washington Post, FDA declined to comment noting their policies against commenting on pending or ongoing litigation.

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